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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.
Jennifer
Anderton
INTER-EWING1@trials.bham.ac.uk
Bernadette
Brennan
Bernadette.Brennan@mft.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
Malignant neoplasms of bone and articular cartilage
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Ewing Sarcoma is a cancer of bone or soft tissue that occurs in children and adults. Treatment usually includes chemotherapy,surgery and/or radiotherapy. Many patients can be cured with this combination; however,survival rates are lower if the tumour has
spread to other areas of the body and/or does not respond to initial treatment,or comes back. INTER-EWING-1 is an international
clinical trial open to patients of all ages,which aims to answer the following key questions:
• Does giving an extra drug (in addition to standard treatment) improve survival for patients where their disease has spread?
• How long should chemotherapy be given – does giving a longer period of less intensive chemotherapy at the end of standard
treatment improve survival?
• For patients whose tumour cannot be removed with surgery,do higher doses of radiotherapy reduce the risk of the tumour coming
back?
• Where the tumour is known to be more likely to come back after an operation (for example,if the tumour is large,or does not
respond to chemotherapy),can lower doses of radiotherapy reduce the side effects but not increase the risk of the tumour coming
back?
In INTER-EWING-1,we want to find if having standard chemotherapy plus a type of drug designed to target tumour cells,called a
multi-tyrosine kinase inhibitor (MTKI) is better for patients. The MTKI regorafenib will be given to patients who have tumours which
have spread to other parts of the body. As this is the first time patients will have been given this combination,initial safety testing will
be done in a separate study first.
In some other cancers,continuing low dose chemotherapy at the end of standard treatment has been shown to improve survival. In
INTER-EWING-1 we want to find if having an additional 6 months of chemotherapy is better for patients or not.
Outcomes for patients after failure to control disease are very poor. INTER-EWING-1 aims to optimise the radiotherapy doses given
to achieve best outcomes.
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: Drug;Radiotherapy;
You can take part if:
You may not be able to take part if:
Exclusion Criteria for study entry 1. Previous malignancy Exclusion criteria for randomisation A will be defined on completion of the externally sponsored phase 1b study. A substantial amendment will be submitted to the relevant competent authority and ethics committee(s) to include these details prior to the opening of Randomisation A. Exclusion Criteria Radiotherapy Randomisations – B1 and B2 1. Previous radiotherapy to the same site 2. Pregnant or breastfeeding women 3. BuMel high dose chemotherapy within previous 10 weeks Randomisation B1 specific Exclusion criteria– Definitive radical radiotherapy dose finding randomisation 1. Patients who have had a R1 or R0 surgical resection of their tumour 2. Previous high dose chemotherapy including busulfan when specified dose constraints to critical organs cannot be met (please see INTER-EWING-1 Quartet RTQA guidelines for more details) Randomisation B2 specific Exclusion criteria– Post-operative radiotherapy dose finding randomisation 1. R2 resection (macroscopic residual tumour) 2. Patients treated by surgery with wide resection (R0 and all tissues involved by the prechemotherapy tumour volume have been completely resected),good histological response (< 10% viable cells),small tumour volume (< 200 mls at diagnosis),of the limb. Randomisation C – Maintenance chemotherapy randomisation Exclusion Criteria 1. Urinary outflow obstruction that cannot be relieved prior to starting treatment 2. Uncontrolled significant inter-current illness or active infection 3. Active inflammation of the urinary bladder (cystitis) 4. Known contraindication or hypersensitivity to any of the treatments or excipients 5. Pregnant or breastfeeding women
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Bernadette
Brennan
Bernadette.Brennan@mft.nhs.uk
Jennifer
Anderton
INTER-EWING1@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by CANCER RESEARCH UK .
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 57638
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