Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study (COPE)
Colorectal Cancer, Non Small Cell Lung Cancer
About this trial
This is an interventional other trial for Colorectal Cancer focused on measuring advanced, metastatic, liquid biopsy, genetic profiling
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years,
- Histology: colorectal cancer, non-small cell lung cancer,
- Locally advanced/unresectable and/or metastatic solid tumor,
- Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Appendix 1),
- Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally > 10 mm,
- No previous systemic treatment for advanced disease,
- Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,
- Eligible to first-line systemic therapy,
- Patient with a social security in compliance with the French law,
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria:
- Radiological evidence of symptomatic or progressive brain metastases,
- Abnormal coagulation contraindicating biopsy,
- Inability to swallow,
- Major problem with intestinal absorption,
- Previous allogeneic bone marrow transplant,
- Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
- Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
- Individuals deprived of liberty or placed under guardianship,
- Pregnant or breast feeding women,
- Previous enrolment in the present study,
- Any contraindication to first-line systemic therapy.
Sites / Locations
- Centre hospitalier de la Côte BasqueRecruiting
- Clinique Tivoli-DucosRecruiting
- Institut BergonieRecruiting
- Polyclinique Bordeaux Nord AquitaineRecruiting
- CHRU BrestRecruiting
- Polyclinique MarzetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
Experimental
No Intervention
Experimental procedure for colorectal cancer
Standard procedure for colorectal cancer
Experimental procedure for non-small cell lung cancer
Standard procedure for non-small cell lung cancer
Patients with Advanced colorectal cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment)
Patients with Advanced colorectal cancer will be managedby initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.
Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment)
Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.