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NCT Number: NCT03914170

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Median Progression free survival (PFS)

    Time frame: Approximately 36 months

    In RAS wt population

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: 9 months

    Rates in RAS wt population

  2. Overall Response Rate

    Time frame: Maximal 6 months

    at the end of 1st line treatment evaluated according RECIST ( Response Evaluation Criteria in Solid Tumours)

  3. Overall Survival

    Time frame: Approximately 36 months

    Defined as the time from the date of initial first line treatment initiation to the date of documented death from any cause

  4. Duration of response

    Time frame: Approximately 36 months

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

    Time frame: Maximal 6 months

    Maximum grade observed throughout the treatment

  6. Liver metastases resection rate

    Time frame: Maximal 6 months

    Resection (R0 / R1 / R2)

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Collaborators

  • Merck Serono International SA

Registry information

Official study 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

Acronym: ESTER

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2019
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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