An observational study to evaluate the safety and efficacy of FOLFIRI / FOLFOX plus Cetuximab as first-line therapy inpatients with KRAS wild-type metastatic Colorectal cancer

Phase 4

• Conditions: Health Condition 1: null- Patients with KRAS wild-type metastatic Colorectal cancer

• Registration Number: CTRI/2010/091/000161
• Lead Sponsor: Merck Specialities Pvt Limited5th Floor , Shivsagar EstateDr. Annie Besant RoadMumbai 400018

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

The eligibility of the patients for this study is based on the

SPC label

- KRAS wild-type status of tumor tissue

- Chemotherapy naïve patients

- Signed written informed consent (at the discretion of

Centre)

Exclusion Criteria

Known severe (grade 3 or 4; U.S. National Cancer Institute ? Common Toxicity Criteria; NCl-CTC)
hypersensitivity reaction to Cetuximab
Pregnancy and Lactation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability evaluated based on the incidence and severity of adverse eventsTimepoint: At the end of study

Secondary Outcome Measures

Name	Time	Method
1. Response rate <br>2. Disease Control Rate (DCR)<br>3. Progression Free Survival (PS)<br>4. Overall Survival (OS)Timepoint: At the end of the study