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: 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

Phase 4, observational study of Cetuximab in combination with FOLFOX/ FOLFIRI as a first line therapy in KRAS wildtype mCRC patients. Treatment duration is till disease progression, followed by a 3 year followup of the patients. It is primarily a safety and tolerability study, with secondary endpoints focussed on response rates, Progression free survival and Overall survival. 100 patients to be recruited , first patient enrolled on 15th November

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• 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 CetuximabPregnancy 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 events	At the end of study

Secondary Outcome Measures

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

Trial Locations

Locations (27)

Ambaa Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Apollo Speciality Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Bhagwan Mahavir Cancer Institute; 🇮🇳 Jaipur, RAJASTHAN, India

BND Onco Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Chittaranjan National Cancer Institute; 🇮🇳 India

D. M. C. & Hospital; 🇮🇳 India

Delwyn Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Dept of Medical Oncology, RGCI; 🇮🇳 Delhi, DELHI, India

Dr. Lalit Sharmas Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Fortis Escorts Hospital; 🇮🇳 Delhi, DELHI, India

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Ambaa Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr. S. S. Nirni

Principal investigator

919849062003

nirni2002@gmail.com