We are inviting you to take part in a research study ...



To be presented on local headed paper RAMPART Clinical TrialWe are inviting you to take part in a research study called RAMPART Please take time to read the following information carefully. Discuss it with friends and relatives if you wish. You are free to decide whether or not to take part in this research study. If you choose not to take part, this will not affect the care you get from your own doctors in any way. Take time to decide whether or not you wish to take part.You may not benefit directly by participating in this study but by taking part and attending follow-up visits you will help us find out if the treatments may benefit kidney cancer patients like you in the future. You can stop taking part in the study at any time, without giving a reason.Ask us if there is anything that is not clear or if you would like more information. Thank you for reading this information. If you decide to take part you will be given a copy of this information sheet and asked to sign a consent form. You will get a copy of the signed form to keep also. Important things to knowThe study is being run by a study team at the Medical Research Council Clinical Trials Unit which is based at University College London (UCL), the MRC CTU at UCL. Throughout this information sheet we will refer to the MRC CTU at UCL (where this study is run from) or UCL (the organisation that is legally responsible for the study). You can find more information about the organisation of the study on the study website rampart-.Immunotherapy is a type of cancer treatment that ‘wakes up’ a patient’s own immune system so it can fight cancer.We are testing two new immunotherapy drugs to determine whether taking one or both may stop or delay your cancer coming back. If you take part you will be allocated at random to one of 3 different groups by a computer program. Neither you nor your doctor will decide which group you will be in. You may receive no study treatment (the current standard-of-care), one drug or two drugs. Like all medicines, the drugs used in this study can have unwanted sideeffects. It is important for you to read the section where these side-effects are described.If you take part in this study, we will ask that you attend regular appointments at the hospital to receive your treatment and to be monitored closely for side-effects. These appointments may take up to half a day depending on the group to which you are allocated. We will also ask you to attend further hospital visits after your treatment has finished so that we can find out how you are.ContentsWhy are we doing this study?Why am I being asked to take part? What do I need to know about the medicines used in this study?What will I need to do if I take part?What are the possible sideeffects?What are the possible benefits of taking part? What are the possible disadvantages and risks of taking part?What biological samples will be collected as part of this studyWhat other sub-studies could I take part in?More information about taking partContacts for further information How to contact usIf you have any questions about this study, please talk to your doctor or nurse:Name of doctor or nurseHospital DepartmentHospitalStreetCity/TownPostcodeTel: XXXX XXX XXXX1Why are we doing this study?How is research done?The best way of knowing whether one treatment is better than another is by carrying out a ‘randomised controlled trial’. A randomised controlled trial compares two or more groups of people: one or more research groups receive the new ‘research’ treatment(s) and a control group receive the existing ‘standard’ treatment. This allows researchers to see whether a new treatment is better than an existing treatment. In this information sheet we call this randomised controlled trial a ‘study’.What is kidney cancer?Cancer starts when cells in the body begin to grow out of control. Cells in nearly any part of the body can become cancer, and can spread to other areas of the body. Kidney cancer is a cancer that starts in the kidneys. It is still called kidney cancer even if it spreads to other parts of the body.If you want to know more about kidney cancer, you can talk to the doctor or nurse who is treating you. You can also find some useful information at the end of this information sheet. How is kidney cancer usually treated?Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer like yours. The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks so that if the cancer does come back further treatment options can be considered as early as possible. What are we trying to find out?We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back. 2Why am I being invited to take part?You are being told about the RAMPART study and invited to take part because you have recently had surgery to remove your kidney cancer. The doctors treating you believe that there is a risk that the cancer may return. 3What do I need to know about the drugs in this study?What is Durvalumab?Durvalumab is a type of treatment called an immunotherapy, and may sometimes be referred to as an ‘anti-PDL1 drug’ or ‘immune checkpoint inhibitor’. It works by helping your own immune system to attack the cancer. Durvalumab is currently being tested by itself or in combination with other treatments in many types of cancer. Early studies have shown that durvalumab works well and has side effects that can usually be controlled. A similar drug, nivolumab, has been shown to be effective in treating a number of different types of cancer (lung cancer, a type of skin cancer called melanoma and kidney cancer that has spread outside the kidneys). For these reasons, we think durvalumab is a worthwhile drug to test for patients like you to see if it will prevent or delay your kidney cancer returning.What is Tremelimumab?Tremelimumab is another immunotherapy treatment for cancer. It may sometimes be called an ‘anti-CTLA4 drug’ or ‘immune checkpoint inhibitor’. It also works by helping your immune system to attack the cancer. It has been shown to be effective in treating a number of different types of cancer, particularly when used in combination with other cancer treatments. A similar drug called ipilimumab has been shown to be effective in combination with nivolumab (the drug that is similar to durvalumab) for treating patients with melanoma (a type of skin cancer) that has spread to their organs. The combination is also being tested in kidney cancer that has spread outside the kidney.4What will I need to do if I take part? Can I definitely take part?Not everyone may be able to take part in this study. We need to do some tests first to see whether you are suitable to take part.You will need to have a CT scan to see if any cancer is still present in your body. If cancer is present you won’t be able to enter the study, but there are other treatment options your doctor will discuss with you.We will ask that you provide blood and urine samples for testing, and you will have an electrocardiogram (ECG). An ECG is a simple, painless test that records the heart's electrical activity. These tests are to make sure that it will be safe for you to take the study drugs.You will also need to join the study within 3 months (91 days) of having surgery to remove your kidney cancer. What if the tests show I can take part?If tests show you are fit to take part and you agree to join the RAMPART study, you will be randomly assigned to one of 3 different groups. These are also known as Groups A, B and C and are shown in the diagram here:Everyone who takes part will be in one of these groups. Which group will I be in? Because we do not know if the new treatments will be better than the current standard of care (no treatment), it is important that the patients in each group are as similar as possible at the start of the study. As we mentioned earlier, a process called randomisation is used to allocate people to each group. We use a computer program to do this. Your doctor will not have any say in which group you are allocated. For every 7 patients entered into the study, 3 will be allocated to Group A, 2 to Group B and 2 to Group C.What will happen to me during the first year on study? If you are allocated to group A:You will not receive any study drugs. During your first year on study you will be asked to attend appointments at your hospital for regular CT scans (see section below entitled ‘What tests and checks will be done’ for more information). Your appointments will take place every 4 months from the day you join the study up to the end of the first year. In total you are expected to have 3 study visits during the first year. If you are allocated to group B:You will be given a dose of durvalumab every 4 weeks for up to one year. During your first year on study you will be asked to attend an appointment at your hospital every 2 weeks during the first eight weeks and then every four weeks for the rest of the year so that your doctor can see how you are doing and so you can have regular blood tests. In total you are expected to have 13 study visits during the first year. If you are allocated to group C:You will be given a dose of durvalumab every 4 weeks for up to one year. You will also receive a dose of tremelimumab at the first two treatment visits (day 1 and week 4). During your first year on study you will be asked to attend an appointment at your hospital every 2 weeks during the first eight weeks and then every four weeks for the rest of the year so that your doctor can see how you are doing and so you can have regular blood tests.You will be seen one month after completing your treatment and two months after that just to make sure all blood results look normal and to check how you are doing. In total you are expected to have 13 study visits during the first year. What will happen to me after completing the first year on study?After the first year on study, all patient groups (A, B and C) will be followed-up in line with the current standard-of-care for patients with kidney cancer. You will be seen after 3 months to make sure all blood results look normal and to check how you are doing. Your doctor will then want to see you for a check-up every 3 months up to the end of year 3, then every 6 months up to year 5 and annually thereafter. Sometimes your doctor may need to see you more frequently. You will continue to have CT scans to check that you kidney cancer has not returned but these will become less frequent over time. This means that all patients are expected to have 17 study visits in total after completing the first year.For further details please see the visit plan in Table 1.How are the drugs given? Both drugs (durvalumab and tremelimumab) are given as infusions. Your nurse will need to put a small tube into a vein in your hand or arm. The drugs are then given directly into the vein. Each infusion will take roughly 1 hour. You will be monitored in hospital during and after the infusion to ensure there are no problems with your treatment.What checks and tests will be done?You will have blood tests for the duration of the study. Some of these tests are additional to those you would normally have as part of routine care but they will be done to coincide with your treatment schedule or hospital visits. As part of routine care you would normally have 10 blood tests. If you choose to participate in the study you will be expected to have up to 12 blood tests if you are in group A and up to 24 blood tests if you are in group B orC. You will also have regular CT scans to check that your kidney cancer has not returned. These are the same type and frequency of scans you would receive if you did not agree to participate in the study, except that there may be an extra one or two in the first year compared to what is standard in some hospitals. In total you are expected to have 12 CT scans as part of the study. During your first year on the study you will have a CT scan every 4 months. The CT scans will continue every 6 months up to year 3, and will then be done at years 4, 5, 7 and 10. Please see the visit plan at the end of this information sheet (Table 1) for full details of the procedures required at each visit.What if I change my mind about taking part? You can stop taking part in all of this study, or in any part of it, at any time and without giving a reason, but we would ask that you talk to your study doctor or nurse first. They may be able to advise you about any concerns you may have. In order to find out if the treatments work as we hope we need to obtain long-term follow up on as many patients as possible. For this reason, we would like to continue gathering information about your health status even if you decide to stop treatment. We can do this in a variety of ways including: collecting information during your clinic visits or from your clinical notes, your doctor or nurse contacting you by telephone or contacting your GP. Your doctor or nurse will talk you through possible options for continuing your follow-up in the most convenient way for you.If you stop taking part in this study, your doctor will discuss options for further treatment with you (which may be active monitoring). A decision to stop taking part at any time will not affect the standard of care you receive.What if my cancer comes back? If a CT scan shows that your cancer has come back you will need to stop any treatment you are receiving as part of the study. You and your doctor will discuss options for further treatment with you. 5What are the possible sideeffects?Durvalumab and tremelimumab are being used in a range of studies in various tumour types. A number of known side-effects of both are listed below. They are still fairly new treatments and so there may be other side effects which we do not know about yet. Most side-effects can be reversed with effective treatment, particularly if detected early. Occasionally, side-effects of these drugs persist longterm, notably diabetes or changes in the function of the thyroid or adrenal gland. These side-effects can generally be managed with tablet treatments. Your doctor and nurse will monitor you closely for any side effects. It is important to let your doctor or nurse know as soon as possible if you notice anything unusual or different during and after treatment. For example if:?you have any new side effects ?your side effects aren’t getting any better?your side effects are getting worse.What are the very common side-effects?Each of these effects happens in more than 1 in 10 people (10%) taking durvalumab on its own or taking durvalumab in combination with tremelimumab. You might have one or more of them. They include:?Cough/productive cough?Diarrhoea?Abdominal pain?Rash/itch?Fever?Upper respiratory tract infection?Feeling sick (nausea)/reduced appetite?Tiredness and weakness (Fatigue)?Joint achesDiarrhoea: If you have 4 or more episodes of loose watery diarrhoea in 24 hours contact your doctor or nurse straight away. You might also have black, tarry, sticky stool, blood or mucus in your stool, severe tummy pain or tenderness. Depending on how severe your symptoms are, you might need treatment such as anti-diarrhoea medicine and fluids into your vein. You may stop treatment temporarily or discontinue treatment altogether if symptoms are severe. Make sure you drink plenty of water. Skin changes: You might notice skin changes such as dryness, itching and rashes on your face, neck and trunk. Tell your doctor if you have any rashes or itching. Don't go swimming if you have a rash because the chlorine in the water can make it worse. If your skin gets dry or itchy, smoothing in unperfumed moisturising cream may help. Check with your doctor or nurse before using any creams or lotions. Wear a high factor sun block if you are going out in the sun.Feeling sick (nausea): Feeling sick is usually well controlled with anti-sickness medicines. Avoiding fatty or fried foods, eating small meals and snacks, drinking plenty of water, and relaxation techniques, can all help. If your symptoms persist, let your medical team know.Pain and swelling in your muscles or joints: Let your doctor or nurse know if you have pain in your joints during or after having treatment. There are lots of ways to treat pain, including relaxation and painkillers.Tiredness and weakness (fatigue): You might feel very tired and as though you lack energy. Various things can help you to reduce tiredness and cope with it, for example exercise. Some research has shown that taking gentle exercise can give you more energy. It is important to balance exercise with resting. Let your medical team know about uncontrolled or worsening fatigue as this could indicate an underlying hormonal condition associated with treatment. Allergy: There is a small chance that you may have an allergic reaction to durvalumab or tremelimumab. While having these drugs you will be closely monitored. You may also have a reaction hours or days after having treatment. It is important to seek urgent medical advice if you develop symptoms like swelling of the skin around the face or tongue, which can lead to difficulty in breathing or swallowing.What are the common side-effects?Each of these effects happens in more than 1 in 100 people (1%) on durvalumab on its own and on durvalumab in combination with tremelimumab. You might have one or more of them. They include:?Voice changes?Changes in liver function resulting in raised liver enzymes, which may indicate damage to the liver. This may rarely lead to jaundice (yellowing of the skin and whites of eyes) and be severe or life-threatening ?Inflammation of the gut which can cause severe diarrhoea?An over or underactive thyroid – a decrease in thyroid function as seen on blood tests may cause you to feel tired, cold or gain weight while an increase in thyroid function may cause you to feel shaky, have a fast pulse or lose weight?Changes in the way the kidney works (raised creatinine in blood)?Painful or difficult urination?Night sweats?Swelling of the ankles or legs?Pneumonia?Oral candidiasis (thrush)?Muscle aches?Allergic reactions (swelling of the skin for example around the face or tongue – this can lead to difficulty in breathing or swallowing)?Flu-like symptoms such as body aches, fevers and chillsDental and mouth infectionsInflammation of the lungs which can cause difficulty in breathing or cough and can be life threatening or fatalWhat are the uncommon side-effects?Each of these effects happens in fewer than 1 in 100 people (<1%). You might have one or more of them. They include:?Inflammation of the liver which may involve nausea, vomiting, abdominal pain and jaundice (yellowing of the skin or the white of eyes), which can be life threatening or fatal on very rare occasions?Reduction in function of the adrenal glands, which might cause problems with salts or other chemicals in the blood, effects on blood pressure, or effects on your ability to recover if you are sick?Inflammation of the kidney, which could lead to reduced kidney function?Dermatitis – severe skin rash?Scarring of the lung which can cause difficulty in breathing?Muscle inflammationWhat are the very rare side-effects?Each of these effects happens in less than 1 in 1000 people. They include:?Type 1 diabetes mellitus, which results in elevated blood sugar levels, and may cause increased thirst, increased urination, weight loss and fatigue?Inflammation of the pituitary gland, which can cause headaches and lead to hormone imbalances which require life-long replacement?Diabetes insipidus (a rare condition where you produce a large amount of urine and often feel thirsty)?Inflammation of the heart muscle,which may cause chest pain, rapid or abnormal heart beat, shortness of breath and swelling of your legs. This can be life-threateningInflammation of the brain which may cause headache, fevers or confusionThe potential side effects of durvalumab and tremelimumab together are the same for durvalumab on its own, as listed above. The side-effects listed below are more common with the two therapies given together:?Tiredness and weakness (fatigue)?A high level of enzymes called amylase and lipase in your blood, which may indicate damage to the pancreas gland, and lead to problems with digestion, abdominal pain, or to diabetes mellitus ?Rash/itch?Swelling of the legs?Changes in liver function resulting in raised liver enzymes (as described above) ?Under active or over active thyroid (as described above)?Reduction in function of the adrenal glands (as described above)?Inflammation of more than one musclePerforation (hole) in the bowel is a rare (less than 1 in 100) but potentially life threatening side-effect of the combination of durvalumab and tremelimumab. If you have any sudden, uncontrolled vomiting with stomach pain and an inability to pass stool (poo) please seek urgent medical attention.Very rare side-effects, with life-threatening consequences that have been seen with drugs that are similar to durvalumab or tremelimumab:Neurological toxicities (for example inflammation of the brain or damage to nerves supplying the limbs, face or breathing muscles): You need to seek urgent medical attention if you develop symptoms such as:weakness in your arms, legs or facechanges in your vision, hearing or sensation changes in your behaviour with or without a fever or headachefits, faints or funny turns What are the effects on pregnancy?The treatments being tested in this study may include unknown risks to an unborn child; therefore pregnant or breast-feeding women will not be allowed to participate in this study. It is also important that study participants do not become pregnant during the course of the study. A pregnancy test will be performed on all women of childbearing potential at the start of the study and prior to each infusion. Female participants of childbearing potential who are sexually active with a male partner who has not been sterilized (vasectomy) will need to an effective method of contraception listed in Table 2. This also applies to a female partner of a male participant. Male participants who have not been sterilized (vasectomy) and who are sexually active with a female partner of childbearing potential must also use a male condom plus spermicide. This will also apply to a male partner of a female participant. Both men and women participating in the study need to be using one of the contraception methods listed in Table 2 for the entire duration of their treatment and up to 6 months after completing it. If you are unsure about an appropriate method of contraception, please speak to your doctor or nurse. Please make sure you speak to your partner about these contraception methods so they are also aware of what is required by this study.Egg or sperm donation is not allowed and breastfeeding must be avoided for the entire duration of treatment and up to 6 months after completing it. It is important you let your doctor or nurse know if you or your partner become pregnant during the course of the study as we will need to check on whether there are any problems for the mother and the child, and we will ask for specific permission to do this.6What are the possible benefits of taking part in this study?We do not know whether you will gain any benefit personally from taking part in this study. However, the information we get from this study will improve our knowledge of treatment for future patients with kidney cancer and potentially change the future standard-of-care for patients like you.7What are the possible disadvantages and risks of taking part? You might experience side-effects from the treatment that you take in this study. Side-effects of durvalumab and tremelimumab are listed in Section 5. Drawing of blood may cause pain or bruising. It is also possible that skin or vein irritation, blood-clot formation, bleeding, bleeding from the injection site, or infection could occur.There is a small chance you might have a reaction from the dye used for your routine CT scans; this risk is small and you will be monitored by the clinical team throughout your CT scan. CT scans use x-rays which are a type of ionising radiation. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The chances of this happening to you as a consequence of routine CT scanning over 120 months is about 2%. Taking part in this study will marginally increase these chances from 2% to 2.1%.You will be asked to attend some extra appointments during year 1 of the study. However, after year 1 the number of follow-up appointments will be the same as if you were not in the study.If you have private medical insurance or require travel insurance, your policy may be affected. You should check this with your insurance provider.Patients and their partners will need to use appropriate contraception listed in Table 2.8What biological samples will be collected as part of this study?It is becoming more and more important to understand how a person’s genetic make up influences their cancer, how they respond to treatment, and why certain side effects are experienced more severely by some people than others. Everyone taking part in RAMPART will already have had surgery to remove part or all of their kidney. In order to take part in the study we ask that all patients allow us to collect some of the tissue that was already removed during surgery. We also ask that patients agree to provide a blood sample before their first infusion. This small blood sample (less than a teaspoon full) will be taken while other blood samples are being done as part of the study or routine clinical care so there won’t be a need to pierce your skin specifically for this.Your research team will send this blood sample to a central laboratory for future analysis. This part of the study is mandatory, i.e. both the tumour and the blood sample must be provided. What will happen to these samples?The collection of any biological samples as part of the study will require collaboration with other institutions outside the MRC CTU at UCL. Your samples will be sent to a central lab at Cambridge University where they will be stored for at least the duration of the study. The samples may be tested to help understand factors that may cause kidney cancer or affect the way the cancer responds to immunotherapy treatments.The samples (or data generated from them) may be shared with other universities, NHS hospitals or commercial collaborators, possibly from outside the European Economic Area (EEA) and who might be using specialised testing methods. Proposals for the use of the samples collected in this study will be assessed on a case-by-case basis by an independent trial oversight committee.Your samples will always be anonymous and the researchers will not be able to trace any of the samples collected back to you. All samples collected will be put together with samples from hundreds or thousands of other people and might be used to develop new treatments or tests in the very long-term. The sample is a gift and we would not expect to share in any profits arising from that research. All data will be analysed for all participants and no individual results will be communicated back to participants.9What other sub-studies could I take part in?We want to know how well people in the trial are feeling and doing. We also want to know how much good they think durvalumab or a combination of durvalumab and tremelimumab needs to do for it to be worthwhile. You may therefore be asked to participate in two sub-studies that involve the completion of questionnaires. The Quality of Life and Health Economics sub-study requires you to complete two very short questionnaires before you start treatment and at 3 of your clinic visits (week 16, month 15 and month 36). You will also be asked to complete the questionnaires if your cancer comes back. Each questionnaire should take less than 5 minutes to complete.The Patient Reported Outcomes sub-study requires you to complete a questionnaire before you start treatment and at 3 of your clinic visits (week 16, month 15 and month 36). This questionnaire should take less than 20 minutes to complete.These sub-studies are both optional and you will be asked during consent whether you wish to take part.10More information about taking partDo I have to take part in the RAMPART study?No, your participation in the RAMPART study is entirely voluntary. It is up to you to decide whether or not to take part. If you decide to take part you will be given this participant information sheet to keep and you will be asked to sign a consent form.If you decide not to take part in this study, you will receive the standard treatment, which is active monitoring (the same as Group A). A decision to not take part at any time will not affect the standard of care you receive.Will I get back any travel costs?There will be no payments to patients who decide they want to take part in this study and additional travel expenses cannot be reimbursed.How will my personal information be used?University College London (UCL) is the sponsor for this study, based in the United Kingdom. UCL will be using information from you and your medical records in order to undertake this study and will act as data controller for this study. UCL will be responsible for looking after your information and using it properly and will keep identifiable information about you for 25 years after the study has finished.Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally – identifiable information possible. You can find out more about how we use your information at ctu.mrc.ac.uk/general/privacy-policyHow will your data be collected and stored? Your hospital will collect information from you and your medical records for this research study in accordance with our instructions. Your hospital will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. UCL will collect information about you for this research study from your hospital. This information will include health information, which is regarded as a special category of information. We will use this information to conduct our research. Individuals from UCL and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your hospital will pass your name, sex, date of birth, NHS number and the first half of your postcode to MRC Clinical Trials Unit at UCL along with the information collected from you and your medical records. Where information could identify you, the information will be held securely with strict arrangements about who can access the information. The people who analyse the information will not identify you. Your hospital will keep identifiable information about you from this study for at least 25 years after the study has finished.UCL will collect information about you, for research, from your hospital site, NHS Digital, Public Health England (PHE), the National Cancer Registration and Analysis Service (NCRAS) or other institutions that might be formed in the future for this purpose. This information will include name, sex, date of birth, NHS number, the first half of your postcode and health information. We will use this information to track your long term health status.Fully anonymised copies of the CT scans taken while you take part in the study will be collected and securely stored. We do this in case we need to verify the results of your CT scans that your doctor will provide us with. Scans will be stored using a Microsoft product called Azure which has been set up to ensure your data is protected and safeguarded. No sensitive or personal information will be kept with your scans.When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with relevant legislation, ethics and NHS research policy requirements. We won't share information with others that can identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance. If there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.Who is organising and funding the study? This study is organised by the MRC CTU at UCL, which has run high quality cancer studies for many years. The study coordination, data collection and analysis and administration will be provided by the MRC CTU at UCL. You can find out more about us at ctu.mrc.ac.uk.The MRC CTU at UCL has overall responsibility for the conduct of the study. We are responsible for ensuring the study is carried out ethically and in the best interests of the study participants. Patient representatives have been involved in the design and management of this study and also in writing this information.The study is funded by Kidney Cancer UK, University College London and by an educational grant from Astra Zeneca, the manufacturer of durvalumab and tremelimumab.Your doctor is not receiving any money or other payment for asking you to be part of the study. A payment will be made to the hospital to cover any additional costs associated with treating and looking after patients who take part in the study.Who has reviewed the RAMPART study?The study has been reviewed by international scientists. It has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA), as well as by London Riverside Research Ethics Committee and your hospital’s Research and Development Office. The IRAS Project ID (219487) is a single reference for all of the reviews which have been conducted.What if new information becomes available during the course of the study?Sometimes during a study, new information becomes available about the drugs that are being studied. If the information is relevant to your taking part in the study, your doctor will explain the new information to you and discuss whether you want to continue on the study. The study will be monitored regularly by independent, expert groups to make sure there is a balance between the potential benefit of the treatments and their side effects compared to active monitoring. If you decide to stop taking part in the study, your doctor will arrange for your care to continue outside of the study.Your doctor might also suggest for other reasons that it is in your best interests to stop taking part in the study. Your doctor will explain the reasons and arrange for your care to continue outside the study. What happens if the RAMPART study stops early?Very occasionally a study is stopped early. If this happens, the reasons will be explained to you and your doctor will arrange for your care to continue outside of the study. What if something goes wrong for me?If you have any concerns about the way you have been approached or treated during the study, please talk to your study doctor or nurse. If you are still unhappy, or if you wish to complain, please use the normal NHS complaints process. If you are harmed by taking part in the study, or if you are harmed because of someone’s negligence, then you may be able to take legal action. What will happen to the results of the RAMPART study?When the study is completed, we will publish a summary of the results on the website of the MRC CTU at UCL (ctu.mrc.ac.uk) and on the study website (rampart-)We will also publish the results in a medical journal, and present the information at medical conferences so that other doctors can see them. You can ask your doctor for a copy of any publication. Your identity and any personal details will be kept confidential. No named information about you will be published in any report of this study. We might want to keep you updated on the study and its progress. We will do this via short communications which the team at your local hospital will circulate as and when needed. You can also subscribe to newsletters via the trial website if you are happy for us to store your email address (held securely and separately from clinical data).11Contacts for further informationIf you want further information about the RAMPART study, contact your study doctor or nurse (see below). [Insert address and telephone number of study doctor and/or nurse]More information is also available on our website rampart-You can also find useful information on kidney cancer here:.uk.ukThank you for taking the time to consider taking part in this study.Table 1. Visit Plan Please note that the procedures highlighted in the table are additional for this study and are not part of routine care. # Pregnancy test will be performed on all women of childbearing potential at the start of the study and prior to each infusion.Table 2. List of contraceptive methodsAll sexually active participants and partners of participants must use one of the followingIf you are female…If you are male…Barrier/Intrauterine methodsCopper T intrauterine deviceMale condom with spermicideLevonogesterel-releasing intrauterine system (e.g Mirena)Hormonal methodsEtonogestrel implants (e.g. Implanon or Norplan)Intravaginal device (e.g. ethinylestradiol and etonogestrel)Medroxyprogesterone injection (e.g. Depo-Provera)Normal and low dose combined oral contraceptive pillNorelgestromin/ethinylestradiol transdermal system (e.g. patches)Desogestrel (e.g. Cerazette) ................
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