Using the Oncogramme® Device to Choose Treatment for Metastatic Colorectal Cancer

Impact of Using the Oncogramme® Device to Select the First Line of Treatment (Chemotherapies +/- Targeted Therapies) for Patients With Metastatic Colorectal Cancer on Progression-free Survival, Treatment Costs, Efficiency and Quality of Life Compared to Usual Patient Care.

This study tests if using the Oncogramme® device to choose chemotherapy can help people with metastatic colorectal cancer get better treatment results compared to standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Oncomedics (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Marseille)
• Trial ID: NCT05299840 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Oncogramme® device in selecting the first line of treatment for patients diagnosed with metastatic colorectal cancer (mCRC). The study aims to improve treatment decisions by utilizing personalized data from the Oncogramme® to guide chemotherapy choices, which may include various combinations of drugs. Eligible participants will be those with confirmed colorectal adenocarcinoma and measurable metastases, who are set to receive standard systemic chemotherapy. The trial will compare outcomes based on treatment decisions made with and without the Oncogramme® results.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically proven metastatic colorectal adenocarcinoma who are eligible for standard systemic chemotherapy.

Not a fit: Patients who have received prior chemotherapy within the last six months or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with metastatic colorectal cancer.

How similar studies have performed: Other studies have shown promise in using personalized treatment approaches for cancer, suggesting potential success for this method, although the specific use of the Oncogramme® device is relatively novel.

Eligibility 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:

* 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.

Where this trial is running

Marseille

• Hôpital Saint Joseph Marseille — Marseille, France (Recruiting)

Study contacts

• Principal investigator: Hervé Perrier, M.D — Hopital Saint Joseph Marseille
• Study coordinator: Christophe Lautrette, PhD

Conditions Metastatic Colorectal Cancer