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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Liquid biopsy
GeneticLiquid biopsy will be performed at cycle 1 day 1 and cycle 2 day of each line of systemic treatment, at each tumor evaluation by Imaging and at confirmation of progression
Treatment groups
332 Participants
are divided into 4 treatment groupsGroup A: Experimental procedure for colorectal cancerExperimental treatment 1 intervention
Group B: Standard procedure for colorectal cancerNo intervention 0 interventions
Group C: Experimental procedure for non-small cell lung cancerExperimental treatment 1 intervention
Group D: Standard procedure for non-small cell lung cancerNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assessment of cancer outcome in terms of overall survival (2 distincts population)
Overall Survival (OS) is defined as the time interval between the date of randomization and the date of death (of any cause).
Time frame
18 monthsSecondary outcomes
1
Proportion of patients with at least one actionable alteration (in 2 distincts populations)
An actionable alteration is determined according to the molecular tumor board.
Time frame
Throughout the study: an average of 18 months2
Proportion of patients treated with a targeted therapy (in 2 distincts populations)
A profiling-based targeted therapy corresponds to a therapy targeting an actionable alteration
Time frame
Throughout the study: an average of 18 monthsSponsors and contacts
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Source ClinicalTrials.gov