Status:
UNKNOWN
Centralized Tumour Board and Secondary Intervention Rate in mCRC
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Charité Universitätsmedizin, Department of Hematology, Oncology and Tumor Immunology
Conditions:
Metastatic Colorectal Cancer
RAS Mutation
Eligibility:
All Genders
18+ years
Brief Summary
This is a randomised, multicentre observational study in patients suffering from RAS mutant mCRC with primarily unresectable metastases, who are planned to be treated with FOLFOXIRI and bevacizumab or...
Eligibility Criteria
Inclusion
- Written informed consent to participate in the study
- Patients ≥ 18 years at the time of signing the informed consent
- Histologically confirmed (in primary tumour or metastasis) UICC stage IV metastatic adenocarcinoma of the colon or rectum (mCRC) with primarily unresectable metastases
- RAS mutant CRC (as determined by local pathology in tissue of primary tumour or metastasis)
- At least one measurable lesion according to RECIST version 1.1 in a CT/MRI scan performed within 28 days prior to start of systemic treatment (first cycle of induction treatment)
- ECOG performance status 0-1
- Patients planned to receive chemotherapy with FOLFOXIRI plus bevacizumab as first-line treatment of metastatic disease. De-escalation of FOLFOXIRI to FOLFIRI or FOLFOX is allowed in case of toxicity.
- Patients can also be included if they had already received ≤ 4 cycles of induction/conversion therapy with FOLFOXIRI plus bevacizumab (including those patients in whom FOLFOXIRI has been de-escalated to FOLFIRI or FOLFOX due to toxicity) and the first restaging has not been conducted prior to randomization.
- Completion of adjuvant therapy for colorectal cancer \> 3 months prior to start of systemic treatment (first cycle of induction treatment).
- Patient's ability for treatment with FOLFOXIRI and bevacizumab according to participating physician's judgement.
Exclusion
- Pregnant or breast-feeding women. Females of childbearing potential (FCBPs) who do not practice adequate contraceptive measures as required according to SmPCs of the administered medicinal products.
- Contraindication to intensive chemotherapy with FOLFOXIRI plus bevacizumab
- Contraindications to treatment with 5-FU, oxaliplatin, folinic acid, irinotecan (FOLFOXIRI) and/or bevacizumab according to SmPCs of the administered medicinal products.
- Patients with confirmed cerebral metastasis. In case of clinical suspicion of brain metastasis, a cranial CT or MRI must be performed to rule out brain metastasis before study inclusion.
- Documentation of \> 5 lung metastases (however, no limitation for the number of metastases in the liver)
- Isolated distant nodal metastasis, isolated peritoneal metastasis or isolated bone metastasis
- Limited legal capacity
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04852250
Start Date
June 1 2021
End Date
March 31 2025
Last Update
April 21 2021
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