Recruiting

Personalized Treatment Selection with Oncogramme® Device for Metastatic Colorectal Cancer

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Study Aim

This study aims to determine the effectiveness of personalized treatment selection using the Oncogramme® Device in improving progression-free survival in individuals with metastatic colorectal cancer.

What is being tested

Oncogramme results available

+ Oncogramme results unavailable

Diagnostic Test
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorOncomedics
Study ContactChristophe Lautrette, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 7, 2023

Actual date on which the first participant was enrolled.

Colorectal cancer is a serious health issue, being the second leading cause of cancer-related deaths in France. Every year, nearly 45,000 new cases are diagnosed, with metastases (spread of cancer) occurring in 40-60% of these cases. The survival rate for those with widespread metastatic disease is quite low, ranging from 5% to 15%. The current treatment approach involves surgery and medication, which can include chemotherapy drugs and targeted therapies. These treatments can be used alone or in combination, but the choice of the first line of chemotherapy largely depends on the doctor's discretion and official recommendations. However, there's no consensus yet to ensure that each patient receives the most effective treatment for their unique case. This is where the Oncogramme® device comes in. Developed by Oncomedics, it's the first functional sensitivity test dedicated to oncology in Europe. It analyses each patient's tumor cells in vitro to compare their responses to different treatments, helping doctors determine the most suitable treatment with potentially fewer side effects. This study aims to explore if the personalization of treatments using the Oncogramme® device can improve patient outcomes, including survival and quality of life, by promoting the best possible clinical response and limiting side effects.

Official TitleImpact 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.
Principal SponsorOncomedics
Study ContactChristophe Lautrette, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Doctors use Oncogramme Device results to choose the best treatment. This device tests how well different drugs work against your specific cancer cells.

Group II

In this group, doctors make treatment decisions based on usual practices, without seeing the results of a special test called Oncogramme® Device.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hôpital Saint Joseph Marseille

Marseille, FranceOpen Hôpital Saint Joseph Marseille in Google Maps
Recruiting
One Study Center