| CTRI Number |
CTRI/2010/091/000161 [Registered on: 24/02/2011] |
| Last Modified On: |
24/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Observational PMS |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EMR062202-517 |
Protocol Number |
| NCT01134666 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S H Advani |
| Designation |
|
| Affiliation |
|
| Address |
SL Raheja Hospital
Mahim West
Mumbai
MAHARASHTRA
400016
India |
| Phone |
022 66529999 |
| Fax |
|
| Email |
shadvani2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajiv Rana |
| Designation |
|
| Affiliation |
Merck Limited |
| Address |
5th Floor , Shivsagar Estate
Dr. Annie Besant Road
Mumbai
MAHARASHTRA
400018
India |
| Phone |
+91-22-66609117 |
| Fax |
+91-22-4936046 |
| Email |
rajiv.rana@merck.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sudipto Chatterjee |
| Designation |
|
| Affiliation |
|
| Address |
6th Floor , Shivsagar Estate
Dr. Annie Besant Road
Mumbai
MAHARASHTRA
400018
India |
| Phone |
+91-22-66609056 |
| Fax |
+91-22-4936046 |
| Email |
sudipto.chatterjee@merck.co.in |
|
|
Source of Monetary or Material Support
|
| Merck Specialities Pvt Limited |
|
|
Primary Sponsor
|
| Name |
Merck Specialities Pvt Limited
5th Floor , Shivsagar Estate
Dr. Annie Besant Road
Mumbai 400018 |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 28 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S. S. Nirni |
Ambaa Hospital |
,-
Hyderabad
ANDHRA PRADESH |
919849062003
nirni2002@gmail.com |
| Dr. Ranjan Kumar Mohapatra |
Apollo Speciality Hospital |
,-
Chennai
TAMIL NADU |
91-9840033512
realpv60@hotmail.com |
| Dr. Naresh Somani |
Bhagwan Mahavir Cancer Institute |
,-
Jaipur
RAJASTHAN |
0141-2700107
drsomani@somexresearch.com |
| Dr Boman Dhabhar |
BND Onco Centre |
,-
Mumbai
MAHARASHTRA |
91-9820344570
drboman@hotmail.com |
| Dr. Jaydip Biswas |
Chittaranjan National Cancer Institute |
,-
|
91-9830026696
drjbiswas.cnci@gmail.com |
| Dr. J. S. Sekhon |
D. M. C. & Hospital |
,-
|
91-9815292928
jagdevsekhon@hotmail.com |
| Dr. Rajeev Bedi |
Delwyn Hospital |
,-
Chandigarh
CHANDIGARH |
919815855338
rajeevbedi@yahoo.co.in |
| Dr. Sunil Kumar Gupta |
Dept of Medical Oncology, RGCI |
,-
New Delhi
DELHI |
91-9811102971
drsgonco@yahoo.com |
| Dr Lalit Sharma |
Dr. Lalit Sharmas Clinic |
67/166, Sector 6, Pratap Nagar, Jaipur, Sanganer, India
Jaipur
RAJASTHAN |
9815292928
drlalit2003@yahoo.com |
| Dr. Rajeev Gupta |
Fortis Escorts Hospital |
,-
New Delhi
DELHI |
91-9779949615
dr_rajeevgupta@rediffmail.com |
| Dr. Chirag Desai |
Hemato-Oncology Clinic Ahmedabad Pvt. Ltd |
,-
Ahmadabad
GUJARAT |
91 -79 4004 2223
chiragdesai.oncology@gmail.com |
| Dr. Harsh Dua |
Indraprastha Apollo Hospitals |
,-
New Delhi
DELHI |
91-9810056002
drharshdua@yahoo.co.in |
| Dr. Puneet Gupta |
Indraprastha Apollo Hospitals |
,-
New Delhi
DELHI |
01126925858/5801
pgcancer@gmail.com |
| Dr. R. Gopal |
Joy Hospital |
,-
|
91-9820192131
rgopal1@gmail.com |
| Dr. S. G. Ramanan |
Kumaran Hospital Pvt Ltd |
,-
Chennai
TAMIL NADU |
91-9840410194
mccf.mog@gmail.com |
| Dr. B. K. Smruti |
Lilavati Hospital |
,-
|
91-9820222964
drsmruti2002@yahoo.co.in |
| Dr. Narayanankutty Warrier |
Medical College Calicut |
,-
|
91-495-2740995
n_goray@rediffmail.com |
| Dr. NVS Ramakrishna |
Medwin Hospitals |
,-
|
040-23206666
rnalla@gmail.com |
| Dr. Sanjay Sharma |
Mumbai Cancer Clinic |
,-
Mumbai
MAHARASHTRA |
91-9820024364
drsanjaysharma5@gmail.com |
| Dr. R. C. Joshi |
Northern Railway Central Hospital |
,-
New Delhi
DELHI |
91-9717630533
joshi_rama@hotmail.com |
| Dr. Vineet Talwar |
Rajiv Gandhi Cancer Institute & Research Centre |
,-
New Delhi
DELHI |
91-9810241512
drvineettalwar@yahoo.com |
| Dr. Minish Jain |
Ruby Hall Clinic |
,-
Pune
MAHARASHTRA |
919823133390
minishjain009@gmail.com |
| Dr. P. K. Das |
Senior Consultant Hemato & Medical Oncologist, Apollo Cancer Institute |
,-
|
91-9810444600
drpratapdas@gmail.com |
| Dr. Sameer Khatri |
Shanti Mukand Hospital |
,-
New Delhi
DELHI |
91-9810381883
drsamkhatri@rediffmail.com |
| Dr. Shiekh Aejaz Aziz |
SKIMS |
,-
Srinagar
JAMMU & KASHMIR |
91-9419415365
saejaz2000@yahoo.co.in |
| Dr. D. P. Singh |
SMS Hospital Jaipur |
,-
Jaipur
RAJASTHAN |
91-094142-63400
drdpsingh@yahoo.com |
| Dr. Jayaprakash Madhavan |
TC 14/ 764 Sreemangalam |
,-
|
91-9447217437
jprakash.madhavan@gmail.com |
| Dr. Vinay Vyas |
Vyas Cancer Care |
,-
|
91-9413063148
vinay25vyas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Care Ethics Committee, Mumbai |
Approved |
| Ethics Committee of Care Institute of Medical Sciences, Ahmedabad |
Approved |
| Institutional Review Board of Ambaa Hospitals, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with KRAS wild-type metastatic Colorectal cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cetuximab + 5-FU + leucovorin + Oxaliplatin/ Irinotecan |
Cetuximab 400mg/m2 loading dose followed by 250mg/m2 weekly OR 500 mg/m2 biweekly in combination FOLFOX/ FOLFIRI |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
Known severe (grade 3 or 4; U.S. National Cancer Institute ? Common Toxicity Criteria; NCl-CTC)
hypersensitivity reaction to Cetuximab
Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability evaluated based on the incidence and severity of adverse events |
At the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Response rate
2. Disease Control Rate (DCR)
3. Progression Free Survival (PS)
4. Overall Survival (OS) |
At the end of the study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |