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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Gillian
Whitfield
gillian.whitfield@christie.nhs.uk
Mr
Mark
Phillips
mark.phillips@ucl.ac.uk
Malignant neoplasms of eye, brain and other parts of central nervous system
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Risks and benefits
There are potential side effects specific to hippocampal sparing whole brain radiotherapy. It is possible that tumour cells are present in the hippocampi that cannot be detected by a scan. Because the left and right hippocampal regions are avoided in ‘hippocampal sparing’ whole brain radiotherapy, if any tumour cells are present in the hippocampi these would not be treated by the radiotherapy. Therefore, there is a small increase in the risk that patients might experience new metastases developing in the hippocampal regions if they receive ‘hippocampal sparing’ whole brain radiotherapy.
The overall risk of this is expected to be small (around 5 to 10 patients per 100 patients). If patients did go on to develop hippocampal metastases, they would not be able to have whole brain radiotherapy. However patients would be assessed to see if stereotactic radiosurgery or drug treatment was suitable for them, and this study will allow such further treatment as the treating doctor considers best for the patient.
In this study we want to find out if avoiding the hippocampi during whole brain radiotherapy (hippocampal sparing whole brain radiotherapy) helps to preserve brain functions like memory and learning. Therefore, if a patient is randomised to have hippocampal sparing whole brain radiotherapy, they could benefit from preservation of these functions of their brain, due to a reduced radiotherapy dose to the hippocampi. The information we get from this study will help improve the treatment of people with brain metastases.
If a patient is randomised to the standard whole brain radiotherapy they will receive radiotherapy as per standard routine practice. Individuals vary in how whole brain radiotherapy affects them. For many, the effect on brain function would not be noticeable, or not unduly troublesome, in day to day life.
Consent
Patients will initially be recruited with consent and will have full capacity at this point, as judged by the recruiting investigator, however patients may lose capacity to consent during the trial. In this case, any samples taken will be retained, and data will continue to be collected. Patients will have full capacity to consent to the intrusive trial procedures (i.e. before and during radiotherapy), and they will also consent to continued use and collection of their data in case they lose capacity to consent. Investigators completing the non-intrusive follow up assessments for patients who have lost capacity to consent will not carry out the trial assessments if it is felt that patients are too ill. Carers/family members will usually be present at each clinic appointment particularly if the patient’s health has deteriorated as they may be asked to assist with questions regarding the patient’s health. Therefore they will be closely involved in most aspects of the patient’s care. If patient’s family or carers request that the patient no longer attends hospital appointments or responds to phone calls regarding their health, then the patient will be withdrawn from the trial.
Additional visits, questionnaires and MRI scans
If a centre chooses to bring patients back to separate additional follow up clinic at the 2, 4, 6, 9, 12, 18 and 24 month points to review patients and complete the study assessments, then this would involve 7 additional clinic visits over a two year period. This could mean additional costs to the patient for travel and parking. At each of these visits, patients will be asked to complete some questionnaires, which typically takes 15 to 20 minutes, and can usually be done while they are waiting to see the doctor. At 5 of the 7 post radiotherapy visits, patients will have to spend some additional time in clinic to complete the tests to assess their brain’s ability to process information, for example word recall tests. These tests will take around 30 minutes to 1 hour. The time spent filling in the questionnaires and doing the brain function tests is extra time patients will need to spend at these clinic visits because of being in the trial.
Patients may also have additional MRI scans. Patients will have regular MRI brain scans during the study to detect new or growing metastases. This would be usual in most centres after neurosurgery or SRS for brain metastases. During an MRI scan patients will be asked to lie still on a table that slides into a large, round tunnel. If a patient suffers from claustrophobia (fear on enclosed spaces), they may find an MRI study uncomfortable. The MRI scan will be noisy so patients will be given earplugs and/or headphones to wear. The scan will last about 30 minutes. If claustrophobia and noise affects the patient badly, they are advised to ask their hospital doctor to give them a medicine to help them relax in time for the scan.
Patients are informed about additional visits, time spent in clinic and MRI scans in the Patient information Sheet.
Translational research
All PIs at centres participating in the RAPPER study (Radiogenomics Assessment of Polymorphisms for Predicting the Effect of Radiotherapy) will be requested to offer this study to HIPPO participants (using the ethically appoved study specific RAPPER information and consent form). This involves collection of a blood samples for DNA extraction and analysis of genetic variation across multiple tumour types. Imaging and neurocognitive substudies aimed at predicting risk of neurocognitive toxicity may be undertaken, subject to further grant function.
Participation in future studies
Taking part in the HIPPO study does not mean that patients cannot take part in other studies in the future. However, it is possible that some future studies of new drug, of new types of imaging, or of radiotherapy treatments might not be open to patients who have had while brain radiotherapy or hippocampal sparing whole brain radiotherapy.
Confidentiality
All information collected will be kept strictly confidential, only the patient’s trial number, date of birth, NHS number and initials will be recorded on case report forms at randomisation and then only the patient’s trial number and initials on subsequent case report forms. Responsible individuals will view identifiable data where relevant and necessary to the research. Consent will be obtained for this. All results will be anonymous. Data will be stored in a secure manner at the UCL Cancer Trial Centre and the trial is registered in accordance with the Data Protection Act 1998 and with the Data Protection Officer at University College London.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Radiotherapy;
You can take part if:
You may not be able to take part if:
• Metastases from small cell carcinoma from any site, haematological malignancy, or central nervous system malignancy, • Leptomeningeal metastases, • Contraindication to MRI imaging with contrast, • Prior radiotherapy to the brain (apart from a single course of SRS for brain metastases completed within 24 weeks of randomisation and within 46 weeks of start of the HIPPO trial treatment), • Prior neurosurgery for brain metastases (apart from a single operation within 24 weeks of randomisation and within 46 weeks of start of HIPPO trial treatment), except that prior neurosurgery will be allowed if : o there is no evidence of residual tumour at the resection site on contrast MRI imaging, or o residual tumour at the resection site has been treated by SRS immediately prior to entering HIPPO, • One or more metastases currently or previously within 5 mm of either hippocampus, • One or more metastases within the brainstem, • One or more SRS treated metastases in close proximity to critical normal organs, unless the local investigator is satisfied that the dose already received by the critical organ allows for subsequent delivery of the HIPPO protocolradiotherapy doses, • Disease specific graded prognostic assessment (DSGPA) score ≤ 1.0 for any of the histologies for which DSGPA has been defined (see Appendix 2), • Past medical history of dementia which is thought to be unrelated to the brain metastases, • Women of childbearing potential who are known to be pregnant, or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University College London and funded by CANCER RESEARCH UK; The Brain Tumour Charity; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 18332
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