| CTRI Number |
CTRI/2018/01/011296 [Registered on: 12/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Therapy used for Carcinoma Gallbladder after Surgery |
|
Scientific Title of Study
|
Adjuvant Chemotherapy versus Adjuvant Chemotherapy/Radiotherapy for Carcinoma Gallbladder- A Randomized Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivendra Singh |
| Designation |
Senior consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Room no. 3054, D Block, Ground floor, Rajiv Gandhi Cancer Institute and Research Centre, Rhini, Sector-5, Delhi. Pncode- 110085
North West
DELHI
110085
India |
| Phone |
9818975024 |
| Fax |
|
| Email |
singh.shivendra@rgcirc.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivendra Singh |
| Designation |
Senior consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Room no. 3054, D Block, Ground floor, Rajiv Gandhi Cancer Institute and Research Centre, Rhini, Sector-5, Delhi. Pncode- 110085
North West
DELHI
110085
India |
| Phone |
9818975024 |
| Fax |
|
| Email |
singh.shivendra@rgcirc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivendra Singh |
| Designation |
Senior consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Room no. 3054, D Block, Ground floor, Rajiv Gandhi Cancer Institute and Research Centre, Rhini, Sector-5, Delhi. Pncode- 110085
Ro
North West
DELHI
110085
India |
| Phone |
9818975024 |
| Fax |
|
| Email |
singh.shivendra@rgcirc.org |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre, Delhi. |
|
|
Primary Sponsor
|
| Name |
Dr Shivendra Singh |
| Address |
Room no. 3054, D Block, Ground floor, Rajiv Gandhi Cancer Institute and Research Centre, Rohini, Sector-5, Delhi. Pincode- 110085 |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivendra Singh |
Rajiv Gancdhi Cancer Institute and Research Centre |
Room No. 3054; Ground Floor;Surgical Oncology Department;D block;Rajiv Gandhi Cancer Institute and Research Centre;Sector 5; Rohini; Delhi 110085
North West
DELHI
North West
DELHI |
9818975024
singh.shivendra@rgcirc.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board of Rajiv Gancdhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Operated for Carcinoma Gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adjuvant chemotherapy with Injection Gemcitabine 1g/m2 |
Adjuvant chemotherapy with Injection Gemcitabine 1g/m2 on day 1 and Day 8 of 21 day cyclefor 6 cycles starting 3 weeks post surgery. |
| Intervention |
Adjuvant concurrent chemoradiotherapy |
External beam radiotherapy (50.4Gy @ 1.8Gy for 28 fraction ). Radiation area will include GB fossa;adjacent liver and regional lymphnodes. Chemotherapy given concurently will be injection fluracil 750mg/m2 on day 1-5 and last 5 days of radiotherapy concurrently |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All resectable Ca GB patients who have undergone R0 resection for Ca GB; Those who have not recieved neoadjuvant treatment; those who donot have stage IV disease. |
|
| ExclusionCriteria |
| Details |
Metastatic disease; R1 resection for Ca GB; Stage IVb disease; Those who have recieved neoadjuvant treatment; Refused consent for adjuvant treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival; Recurrence free survival |
6 month; 1 year; 3 year; 5 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pattern of recurrence; Toxicity/Complication of chemotherapy and Chemoradiotherapy |
in 30 days of completion of therapy;6month; 1 year; 3 year; 5 year. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective , double arm, single centric, randomized control trial to compare the benefits of adjuvant Chemotherapy versus adjuvant Chemotherapy/Radiotherapy for Carcinoma Gallbladder in 150 consecutive patients of potentially resectable GBC (Gall bladder cancer) who achieved R0 resection and did not recieve any neoadjuvant treatment. Our hypothesis is that patients who recieved adjuvant concurrent chemoradiation have superior overall survival. Our primary outcome would be to measure overall survival and recurrence free survival, and secondary outcome would be to know about the pattern of recurrence and study toxicity/complications of chemotherapy and chemoradiotherapy. Patients will be randomized to either arm after completion of 3 weeks from surgery. At present there is no standard protocol for adjuvant treatment after curative resection of gall bladder cancer in literature. |