ORCHESTRA trial
Research type
Research Study
Full title
A randomized multicenter clinical trial for patients with multi-organ, colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone.
IRAS ID
255338
Contact name
H. Verheul
Contact email
Sponsor organisation
Radboud University Medical Center, Department of Medical Oncology
Eudract number
2011-005003-32
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
38459, Dutch general assessment and registration form
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
Bowel cancer is the third most common cancer worldwide and the second leading cause of cancer death in the United Kingdom. In both early stage and when it has spread, curative treatment is only possible with complete removal of the tumour through surgery. In recent years, removal of areas where the tumour has spread to (called metastases) in patients with limited disease has improved survival. Besides surgery, several techniques have become available for local treatment of metastases, including radiation therapy or local treatment of the tumour by a technique called ablation or local administration of chemotherapy into the tumour (called transarterial chemoembolisation). Local treatment of metastases of patients with metastatic bowel cancer is often technically feasible, but effects on survival and quality of life have not been studied in patients with more extensive spread from bowel cancer.
The standard treatment of extensive spread from bowel cancer is systemic chemotherapy. This study is a randomised multicenter clinical trial for patients with extensive metastatases from bowel cancer, comparing the combination of chemotherapy and maximal tumour debulking versus chemotherapy alone. Debulking means that as many visible tumors as possible are removed by surgery or other means. The term “randomised”means the trial will decide on the treatment given. It is hoped the trial will show whether adding tumor debulking to chemotherapy will increase patient’s survival. Patients with extensive metastatic bowel cancer with an indication for chemotherapy are eligible for study participation, if a minimum of 80% of all the tumour deposits is deemed feasible by the study team.
After inclusion all patients will receive 3 cycles of chemotherapy, followed by a CT scan. In patients where the disease has remained stable (not increased in size) or responded to chemotherapy (the disease has shrunk), will be randomised between additional tumor debulking treatment or continue with the standard chemotherapy alone. Local treatment of the metastases can consist of surgery, radiation therapy or local treatment of the tumour by ablation or local administration of chemotherapy into the tumour. Data will be gathered by laboratory analysis, tumor markers, CT or PET CT scans and quality of life questionnaires. If successful, this study may define a new standard of care for most metastatic bowel cancer patients.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0261
Date of REC Opinion
6 Sep 2019
REC opinion
Further Information Favourable Opinion