Clinical trial NCT03914170: Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer
Official title: A Retrospective Study Assessing the Efficacy and Safety of Triplet Chemotherapy (FOLFIRINOX) Fluorouracil + Oxaliplatin + Irinotecan Plus Cetuximab (ERBITUX®) as First Line Treatment in a RAS (Ras Sarcoma Viral Oncogene Homolog) (KRAS, NRAS) Wild-type Metastatic Colorectal Cancer Population According to BRAF (Murine Sarcoma Viral Oncogene Homolog B) Status and Primary Tumor Location
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
first line
folfirinox + cetuximab
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2019-04-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

Detailed description: In Europe, there are 447,000 new cases of colorectal cancer each year. Approximately 25% of patients present with metastases at initial diagnosis and almost 50% of patients with mCRC (metastatic colorectal cancer) will develop metastases

. 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.

Eligibility criteria: Inclusion Criteria:

1. Colorectal cancer confirmed as RAS wild by tumor tissue analysis
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:

1. Known brain metastases
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

Primary outcomes:
measure: Median Progression free survival (PFS)
timeFrame: Approximately 36 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 9 months
measure: Overall Response Rate
timeFrame: Maximal 6 months
measure: Overall Survival
timeFrame: Approximately 36 months
measure: Duration of response
timeFrame: Approximately 36 months
measure: Assessment of adverse events by using the NCI-CTCAE version 4.0 scale
timeFrame: Maximal 6 months
measure: Liver metastases resection rate
timeFrame: Maximal 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du cancer de Montpellier
state: Hérault
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: Emmanuelle SAMALIN, MD
role: PRINCIPAL_INVESTIGATOR
References: