Informations générales (source: ClinicalTrials.gov)
Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study (COPE)
Interventional
N/A
Institut Bergonié (Voir sur ClinicalTrials)
septembre 2020
avril 2025
05 avril 2025
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Institut Bergonie - 33076 - Bordeaux - France | Antoine ITALIANO, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier de la Côte Basque - 64109 - Bayonne - France | Thomas GRELLETY, MD | Contact (sur clinicalTrials) | |||
| CHRU Brest - 29200 - Brest - France | Jean-Philippe METGES, MD,PhD | Contact (sur clinicalTrials) | |||
| Clinique Tivoli-Ducos - 33000 - Bordeaux - France | Valérie COCHIN, MD | Contact (sur clinicalTrials) | |||
| Polyclinique Bordeaux Nord Aquitaine - 33077 - Bordeaux - France | Cédric LECAILLE, MD | Contact (sur clinicalTrials) | |||
| Polyclinique Marzet - 64000 - Pau - France | Sylvestre LE MOULEC, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Age ≥ 18 years,
2. Histology: colorectal cancer, non-small cell lung cancer,
3. Locally advanced/unresectable and/or metastatic solid tumor,
4. Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Appendix 1),
5. 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,
6. No previous systemic treatment for advanced disease,
7. Availability of suitable paraffin embedded (FFPE) archive tumor material or at least
one target lesion that can be biopsied for research purpose,
8. Eligible to first-line systemic therapy,
9. Patient with a social security in compliance with the French law,
10. Voluntary signed and dated written informed consent prior to any study specific
procedure.
1. Age ≥ 18 years,
2. Histology: colorectal cancer, non-small cell lung cancer,
3. Locally advanced/unresectable and/or metastatic solid tumor,
4. Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Appendix 1),
5. 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,
6. No previous systemic treatment for advanced disease,
7. Availability of suitable paraffin embedded (FFPE) archive tumor material or at least
one target lesion that can be biopsied for research purpose,
8. Eligible to first-line systemic therapy,
9. Patient with a social security in compliance with the French law,
10. Voluntary signed and dated written informed consent prior to any study specific
procedure.
1. Inability to swallow,
2. Major problem with intestinal absorption,
3. Previous allogeneic bone marrow transplant,
4. 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,
5. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension,
active bleeding diatheses, or active Hepatitis B, C and HIV),
6. 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,
7. Individuals deprived of liberty or placed under guardianship,
8. Pregnant or breast feeding women,
9. Previous enrolment in the present study,
10. Any contraindication to first-line systemic therapy.