Actively Recruiting
Impact of Using the Oncogramme® Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer
Led by Oncomedics · Updated on 2025-03-27
450
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
Sponsors
O
Oncomedics
Lead Sponsor
H
Hospital St. Joseph, Marseille, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 in 40-60% of colorectal cancer cases. The 5-year survival rate ranges from 5% to 15% for patients with widespread metastatic disease. Two types of treatments are used to treat colon cancer: surgery and medication protocol (chemotherapeutic drugs and targeted therapies). These treatments can be used alone or in combination. The current choice of a first line of chemotherapy is left to the practitioner's discretion, after consultation with a multidisciplinary consultation meeting. The choice of treatment(s) depends on official recommendations and is based on the results of clinical trials conducted on large populations, and takes into account the toxicities of the therapies used and the general condition of the patients. The therapeutic combinations for colorectal cancers are therefore multiple. However, to date, no consensus has been reached to ensure that each patient is treated effectively and as a unique case. Today, functional sensitivity tests offer the possibility for patients to be offered a personalized treatment against cancer. This is the case of the Oncogramme® device developed by Oncomedics, which is the first functional sensitivity test dedicated to oncology in Europe. It is based on 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. This test is therefore likely to improve the benefit-risk ratio of a chemotherapy treatment in colorectal cancer by allowing the medical team to select, among the treatments deemed effective, the one that will be the most effective on the tumor and possibly with the least side effects. The hypothesis of this study is that the personalization of treatments (by chemotherapy associated or not with targeted therapies) proposed by the Oncogramme®-colorectal device would allow to promote the best possible clinical response, to limit the side effects and ultimately to improve the survival and the quality of life of the patient.
CONDITIONS
Official Title
Impact of Using the Oncogramme® Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old and older
- Diagnosed or suspected metastatic colorectal cancer (with synchronous or metachronous metastases requiring biopsy)
- Eligible for standard systemic chemotherapy including multidrug regimens like FOLFOX, FOLFIRI, or FOLFIRINOX, possibly combined with targeted therapies
- Histologically confirmed colorectal adenocarcinoma
- At least one measurable metastasis according to RECIST v1.1
- Receiving chemotherapy for curative or palliative purposes
- Oncogramme� test can be performed
- WHO performance status score of 2 or less
- Life expectancy greater than 3 months
- Adequate blood counts: neutrophils above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL
- Liver and kidney function within specified limits
- No prior chemotherapy except peri-operative or adjuvant chemotherapy stopped more than 6 months ago
- Creatinine clearance above 50 mL/min
- Affiliated with a social security scheme
- Provided informed consent
You will not qualify if you...
- Eligible for curative treatments like surgery for isolated liver metastases
- Metachronous metastases not requiring biopsy
- Recent severe heart conditions or stroke within 6 months
- Uncontrolled high blood pressure
- Recent history of abdominal fistula, gastrointestinal perforation, abscess, or active bleeding
- Active peptic ulcer
- Unhealed deep wounds or bone fractures less than 3 months old
- Major surgery within 4 weeks before treatment
- Radiotherapy within 4 weeks before treatment
- Transplant recipients, HIV positive, or other immunodeficiencies
- Previous chemotherapy except certain adjuvant treatments stopped over 6 months ago
- Unstable progressive liver, kidney, or lung disease in last 6 months
- Peripheral neuropathy above grade 1
- Interstitial lung disease or pulmonary fibrosis
- History of chronic diarrhea, inflammatory bowel disease, or unresolved bowel obstruction
- Recent other cancers within 5 years except some treated skin or cervical cancers
- Currently enrolled in another drug trial or recently exited one
- Known allergies or contraindications to study drugs
- Known enzyme deficiency affecting drug metabolism
- Abnormal heart rhythm intervals
- Low potassium, magnesium, or calcium levels
- Lack of effective contraception for patients of childbearing potential
- Pregnant or breastfeeding women
- Persons deprived of liberty or under guardianship
- Unable to follow medical study requirements due to geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Saint Joseph Marseille
Marseille, France, 13008
Actively Recruiting
Research Team
C
Christophe Lautrette, PhD
CONTACT
S
Stéphanie Giraud, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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