Study Stopped
The study was discontinued due to slow recruitment and subjects not completing follow up period.
An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
1 other identifier
observational
165
1 country
40
Brief Summary
This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2014
CompletedJune 9, 2017
June 1, 2017
3.7 years
May 28, 2010
June 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability evaluated based on the incidence and severity of AEs.
From baseline to follow-up visit for any ongoing AEs
Secondary Outcomes (1)
Response rate
Baseline to End-of-Study Visit
Interventions
FOLFOX Oxaliplatin 100 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 FOLFIRI Irinotecan 180 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 CETUXIMAB Cetuximab administered at loading dose of 400 mg/m2/week over 120 min followed by maintenance dose of 250 mg/m2/ week over 60 min, till disease progression or dose limiting toxicity
Eligibility Criteria
Subjects with KRAS wild-type CRC receiving FOLFOX/FOLFIRI and cetuximab in India.
You may qualify if:
- Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
- Subjects with KRAS wild-type status of tumour tissue
- Chemotherapy naïve subjects
- Subject who have signed written informed consent (as per institutional protocol)
You may not qualify if:
- As per summary of product characteristics of cetuximab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck KGaA, Darmstadt, Germanylead
- Merck Ltd., Indiacollaborator
Study Sites (40)
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, 500034, India
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, 500063, India
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, 500025, India
Nikhil Gharyalpatil's Clinic
Secunderabad, Andhra Pradesh, 500025, India
Ravi Kumar's Clinic
Hyderabad, Andrapradesh, 500001, India
Ambaa Hospitals
Hyderabad, Andrapradesh, 500008, India
Swarna Sai Hospital
Hyderabad, Andrapradesh, 500059, India
Manipal Centre For Clinical Research
Mangalore, Bangalore, 575 001, India
Medical College Calicut
Kerala, Calicut, 673016, India
Hemato Oncology Clinic
Ahmedabad, Gujarat, 380009, India
SKIMS
Srinagar, Jammu and Kashmir, 190001, India
S. K. I. M. S.
Srinagar, Jammu and Kashmir, 190010, India
Kattimani Oncology Clinic
Hubli, Karnataka, 580020, India
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, 462001, India
BND Onco Centre
Mumbai, Maharashtra, 400014, India
Joy Hospital
Mumbai, Maharashtra, 400071, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Grace Nursing Home
Aizawl, Mizoram, 796 009, India
Lilavati Hospital
Bandra, Mumbai, 400050, India
S.L.Raheja Hospital
Mahīm, Mumbai, 400016, India
Apollo Cancer Institute
Delhi, New Delhi, 110044, India
Rajiv Gandhi Cancer Institute & Research
Delhi, New Delhi, 110085, India
Fortis Escorts Hospital
Amritsar, Punjab, 143004, India
Dr. Rajeev Bedi's Clinic
Chandigarh, Punjab, 160101, India
D.M.C Hospital
Ludhiana, Punjab, 141001, India
IVY Hospital
Mohali, Punjab, 160071, India
Cancer Clinic
Jaipur, Rajasthan, 302004, India
SMS Hospital
Jaipur, Rajasthan, 302004, India
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, 302006, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, Rajasthan, 302030, India
Vyas Cancer Care
Jodhpur, Rajasthan, 3420003, India
TC 14/ 764 Sreemangalam
Trivandrum, Tamil Nadu, 695011, India
Shati Gopal Hospital
Ghaziabad, Uttar Pradesh, 201014, India
Annapurna Medical and Cancer Relief Society
Lucknow, Uttar Pradesh, 226007, India
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026, India
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, 700054, India
Nothern Railway Central Hospital
Delhi, 110055, India
Indraprastha Apollo Hospital
Delhi, 110076, India
Shanti Mukand Hospital
Delhi, 110092, India
Dharamshila Cancer Hospital & Research Centre
Delhi, 110096, India
Biospecimen
Whole Blood and Tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rajiv Rana, MD
Merck Ltd., India
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
November 30, 2009
Primary Completion
July 31, 2013
Study Completion
August 5, 2014
Last Updated
June 9, 2017
Record last verified: 2017-06