Personalized Treatment Selection with Oncogramme® Device for Metastatic Colorectal Cancer
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.
Oncogramme results available
+ Oncogramme results unavailable
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.450 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
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