| CTRI Number |
CTRI/2010/091/000170 [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 Cetuximab in combination with platinum-based chemotherapy, in the first-line therapy of recurrent/ metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) |
|
Scientific Title of Study
|
An Observational Study to evaluate the safety and efficacy of Cetuximab in combination with platinum-based chemotherapy, in the first-line therapy of recurrent/ metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EMR 62202-514 |
Protocol Number |
| NCT01142869 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SH Advani |
| Designation |
|
| Affiliation |
|
| Address |
SL Raheja Hospital
Mahim West
Mumbai
MAHARASHTRA
400016
India |
| Phone |
02266529999 |
| Fax |
|
| Email |
shadvani2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajiv Rana |
| Designation |
|
| Affiliation |
Merck Limited |
| Address |
5th Floor Shiv Sagar Estate
Dr. Aniie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
+91-22-6669117 |
| Fax |
+91-22-24936046 |
| Email |
rajiv.rana@merck.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sudipto Chatterjee |
| Designation |
|
| Affiliation |
|
| Address |
5th Floor Shiv Sagar Estate
Dr. Aniie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
+91-22-66609056 |
| Fax |
+91-22-24936046 |
| Email |
sudipto.chatterjee@merck.co.in |
|
|
Source of Monetary or Material Support
|
| Merck Specialities Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Merck Specialities Pvt Ltd
5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, Worli
Mumbai 400018 |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S. M. Karandikar |
2, Sweta corner,7th Lane, Prabhat road, 38/19, Erandwane,Pune-411004,Maharashtra |
,-
|
91-9890281963
skaran44@gmail.com |
| Dr. M. C. Kar |
B.R.Singh Railway Hospital |
,-
|
91-9830155915
madhuchandakar@yahoo.com |
| Dr. Naresh Somani |
Bhagwan Mahavir Cancer Institute |
,-
|
0141-2700107
drsomani@somexresearch.com |
| DrBoman Dhabhar |
BND ONCO CENTRE |
BND ONCO CENTRE,808, Boman Lodge,Dr. Ambedkar Road,Dadar TT,Dadar (East),Mumbai,India.
Mumbai
MAHARASHTRA |
9820344570
drboman@hotmail.com |
| Dr. Jaydip Biswas |
Chittaranjan National Cancer Institute |
,-
Kolkata
WEST BENGAL |
91-9830026696
drjbiswas.cnci@gmail.com |
| Dr NVS Ramakrishna |
Dr. NVS Ramakrishnas Clinic |
5-9-22/8/A, Adarsh Nagar, Near Birla Mandir, Hyderabad-500 063
Hyderabad
ANDHRA PRADESH |
9949341112
rnalla@gmail.com |
| Dr. Shailesh Puntambekar |
Galaxy Care Laproscopic Institute |
,-
|
shase63@gmail.com |
| Dr. Atul Sharma |
Institute Rotary Cancer Hospital |
,-
|
91-9818548149
atul1@hotmail.com |
| Dr Sharad Singh |
J.K.Cancer Institute |
,-
|
91-9452062985
sharad_onco@yahoo.co.in |
| Dr. Ashok Vaid |
Medanta The Medicity |
,-
|
91-9810212235
akvaid@yahoo.com |
| Dr. K. C. Mishra |
Meherbai Tata Memorial Hospital |
,-
|
91-99939630090
mishrakc1960@gmail.com |
| Dr. D. K. Parida |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
,-
|
94361-14334
dkparida@hotmail.com |
| Dr, Satya Palanki Dattatreya |
Omega Hospital |
,-
Hyderabad
ANDHRA PRADESH |
91-9440591396
satya_palanki@rediffmail.com |
| Dr. Arundhati Charaborty |
Palliative Care Specialists Unit |
,-
Kolkata
WEST BENGAL |
91-9831742166
arundhatic@rediffmail.com |
| Dr. Minish Jain |
Ruby Hall Clinic |
,-
Pune
MAHARASHTRA |
91-9823133390
minishjain009@gmail.com |
| Dr. D. P. Singh |
SMS Hospital |
,-
Jaipur
RAJASTHAN |
094142-63400
drdpsingh@yahoo.com |
| Dr. Ghanshyam Biswas |
Sparsh Hospital and Critical Care P Ltd |
,-
|
919937500878
drgbiswas@yahoo.com |
| Dr.Thomas Varughese |
The Cancer Clinic |
,-
|
|
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Care Ethics Committee |
Approved |
| Medanta Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Recurrent/ Metastatic Squamous Cell Carcinoma of Head
and Neck (SCCHN), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cetuximab in combination Platinum based Chemotherapy |
The initial dose is 400 mg per m2 body surface area (BSA). The subsequent weekly doses are 250 mg/m2 each. For the initial dose, the recommended infusion period is 120 minutes. For the subsequent weekly doses, the recommended infusion period is 60 minutes. Treatment is to be continued till disease progression or DLT |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The study inclusion criteria is as per the local SPC: ?Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.?
For each platinum-based chemotherapy, the related product labels approved by India Health Authorities should also be followed strictly in terms of patient eligibility. |
|
| ExclusionCriteria |
| Details |
Patients with known severe (grade 3 or 4; NCI-CTC) hypersensitivity reactions to
Cetuximab are contraindicated for Cetuximab |
|
|
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) |
27/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
This is a Phase IV Observational study in recurrent and or metastatic Squamous Cell Carcinoma of Head & Neck. The study involves treatment with Cetuximab in combination with Platinum based Chemotherapy in this subset of patients. It is a prospective study wherein safety and efficacy data would be collected over a duration of 2 years from initiation of therapy |