Status:
RECRUITING
Impact of Using the Oncogramme® Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Oncomedics
Collaborating Sponsors:
Hospital St. Joseph, Marseille, France
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen i...
Eligibility Criteria
Inclusion
- 18 years old and older
- Patient with suspected mCRC (synchronous or metachronous metastases (only if biopsy is required as part of routine care))
- Patient eligible for standard systemic chemotherapy (multidrug therapy such as FOLFOX, FOLFIRI, FOLFIRINOX, combined or not with anti- EGFR or anti-VEGF targeted therapies adapted to BRAF and RAS expression)
- colorectal adenocarcinoma histologically proven
- At least one measurable metastasis according to RECIST v1.1
- Chemotherapy for curative or palliative purposes
- Oncograms® can be performed
- WHO score ≤ 2
- Life expectancy \> 3 months
- neutrophils \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dL
- Total bilirubin \< 25 μmol/L, aspartate aminotransferase \< 5 ULN (upper limits of normal), alanine aminotransferase \< 5 ULN, alkaline phosphatase \< 5 ULN, prothrombin rate \> 60%, proteinuria \< 1 g/24h
- No prior chemotherapy except peri-operative or adjuvant chemotherapy stopped more than 6 months ago
- Creatinine clearance \> 50 mL/min according to MDRD formula
- Patient affiliated to a social security scheme
- Information to the patient and signature of the informed consent form.
Exclusion
- Patients eligible for curative treatment (surgical and/or percutaneous) after discussion in multidisciplinary consultation meeting (isolated class I liver metastases)
- Patients with metachronous metastases not requiring biopsy as part of their standard management.
- Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, New York Heart Association (NYHA) class II, III, or IV congestive heart failure, stroke, or transient ischemic attack within 6 months prior to inclusion
- HTA not controlled by medical treatment (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg)
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
- Active peptic ulcer
- Deep wound or bone fracture not resolved within 3 months
- Major abdominal or extra-abdominal surgical procedure (except diagnostic biopsy or implantable site placement)
- Irradiation within 4 weeks prior to the start of treatment
- Transplant patients, HIV-positive, or other immunodeficiency syndromes
- Previous chemotherapy (except peri-operative or adjuvant chemotherapy discontinued more than 6 months ago)
- Any progressive disease not balanced during the last 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency
- Peripheral neuropathy \> 1 (CTCAE Common terminology criteria for adverse eventsv5.0)
- Patient with interstitial lung disease or pulmonary fibrosis
- History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion unresolved with symptomatic treatment
- History of malignancy within the last 5 years except for properly treated non-metastatic colon cancer, basal cell skin carcinoma or carcinoma in situ of the uterine cervix
- Patient already included in another therapeutic trial with an investigational treatment or who has been out of a trial for less than 6 months
- Any specific contraindication or known allergy to the drugs used in the study.
- Known dihydropyrimidine dehydrogenase deficiency
- QT/QTc interval \> 450 ms for men and \> 470 ms for women
- Kalemia (K+) \< LIN (lower limit to normal), magnesemia (Mg2+)\< LIN, calcemia (Ca2+)\< LIN
- Lack of effective contraception (at least 2 different means) in patients (male or/and female) of childbearing age, or for females, 12 months of confirmed amenorrhea, pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test (serum test)
- Persons deprived of liberty or under guardianship
- Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
Key Trial Info
Start Date :
June 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05299840
Start Date
June 7 2023
End Date
December 1 2028
Last Update
March 27 2025
Active Locations (1)
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1
Hôpital Saint Joseph Marseille
Marseille, France, 13008