Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer
NCT ID: NCT03914170
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2017-04-01
2018-04-01
Brief Summary
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Detailed Description
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. Chemotherapy represents the backbone of treatment, and survival is linked with the administration of all three active cytotoxic agents (5-fluorouracil/folinate, oxaliplatin, and irinotecan) in the first line treatment of metastatic colorectal disease.
Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS (rat sarcoma viral oncogene homolog) wild type metastatic colorectal cancer (mCRC).
Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy (response rate, resectability...), but at the price of an increased rate of toxic effects.
This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type mCRC (metastatic colorectal cancer) population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Folfirinox + cetuximab
Cetuximab 250 mg/m² iv infusion for 2h, Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h, Irinotecan 180 mg/m² iv infusion, 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles max)
Eligibility Criteria
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Inclusion Criteria
2. Non resectable and measurable metastatic disease
3. Patients treated with FOLFIRINOX + cetuximab in first line metastatic disease
4. Males or females aged over 18 years.
Exclusion Criteria
2. RAS not assessable (e.g., material not available or insufficient)
3. The first administration of cetuximab was more than 30 days after the first administration of FOLFIRINOX
4. History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years
18 Years
ALL
No
Sponsors
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Merck Serono International SA
INDUSTRY
Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Emmanuelle SAMALIN, MD
Role: PRINCIPAL_INVESTIGATOR
Institut régional du cancer de Montpellier
Locations
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Institut régional du cancer de Montpellier
Montpellier, Hérault, France
Countries
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Other Identifiers
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ICM-URC2016/31
Identifier Type: -
Identifier Source: org_study_id
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