Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Bergonié
About this trial
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients.
For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B:
* Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis) * Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).
Eligibility criteria
Qualifiers
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),
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Liquid biopsy
Treatment groups
332 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov