Impact of Using the Oncogramme(R) Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer

Program Status

Recruiting

Phase

Not Applicable

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Trial only in Francia. Only for metastatic CRC patients who are about to start treatment.
The study offers the chance (by random assignation to one arm) of having the Oncogramme® test. For the patients in the Oncogramme group, the oncologist has access to the results of the test and decides on the treatment according to the recommendations of the Oncogramme® Device. This test is an in vitro analysis of each patient’s tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available (chemotherapy ± targeted therapy). This response, translated into a tumor-specific sensitivity profile, can be used by the medical team to determine the most appropriate treatment for the patient.

Location Location Status
France
Hôpital Saint Joseph Marseille
Marseille 13008
Recruiting

Contacts

Christophe Lautrette, PhD
CONTACT
0033 5 55 33 85 25 c.lautrette@oncomedics.com
Stéphanie Giraud, PhD
CONTACT
0033 5 55 33 85 25 s.giraud@oncomedics.com

Inclusion Criteria

Inclusion Criteria:

* 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 Criteria

Exclusion Criteria:

* 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.

NCT ID

NCT05299840

Date Trial Added

2022-03-29

Updated Date

2025-03-27