Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer

NCT03914170 | Completed

• 1 other identifier: ICM-URC2016/31
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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 metastatic colorectal cancer population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; first line; folfirinox + cetuximab

Outcome Measures

Primary Outcomes (1)

• Median Progression free survival (PFS)

  In RAS wt population

  Approximately 36 months

Secondary Outcomes (6)

• Progression free survival (PFS)

  9 months

• Overall Response Rate

  Maximal 6 months

• Overall Survival

  Approximately 36 months

• Duration of response

  Approximately 36 months

• Assessment of adverse events by using the NCI-CTCAE version 4.0 scale

  Maximal 6 months

Interventions

Folfirinox + cetuximab DRUG

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received FOLFIRINOX plus cetuximab (Erbitux®) in first line metastatic colorectal cancer, identified in 3 studies and Medical files from ICM in France: * Medical files from ICM (Montpellier) * UNICANCER- PRODIGE 14 study * ERBIRINOX study * EREBUS study

You may qualify if:

• Colorectal cancer confirmed as RAS wild by tumor tissue analysis
• Non resectable and measurable metastatic disease
• Patients treated with FOLFIRINOX + cetuximab in first line metastatic disease
• Males or females aged over 18 years.

You may not qualify if:

• Known brain metastases
• RAS not assessable (e.g., material not available or insufficient)
• The first administration of cetuximab was more than 30 days after the first administration of FOLFIRINOX
• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead
• Merck Serono International SA: collaborator

Study Sites (1)

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

folfirinox; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Emmanuelle SAMALIN, MD

  Institut régional du cancer de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: April 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)