| CTRI Number |
CTRI/2025/02/080472 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF HEALTH RELATED QUALITY OF LIFE AND OVERALL SURVIVALS IN PARTICIPANTS RECEIVING CAPECITABINE V/S PARTICIPANTS RECEIVING GEMCITABINE AND OXALIPLATIN.
MAIN OUTCOME IS TO COMPARE QUALITY OF LIFE IN BOTH GROUP OF PARTICIPANTS |
|
Scientific Title of Study
|
COMPARISON OF HEALTH RELATED QUALITY OF LIFE AND OVERALL SURVIVAL IN PATIENTS OF METASTATIC CARCINOMA GALL BLADDER RECEIVING CAPECITABINE ALONE V/S GEMCITABINE AND OXALIPLATIN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikesh jaiswal |
| Designation |
Junior Resident |
| Affiliation |
Post-Graduate Institute of Medical Education and Research |
| Address |
General surgery department , Post-Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
8235919557 |
| Fax |
|
| Email |
Jaiswalnikesh7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
RN SANTHOSH IRRINKI |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
General surgery department, Post-Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
9914492255 |
| Fax |
|
| Email |
Narayanairrinki@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RN SANTHOSH IRRINKI |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
General surgery department, Post Graduate Institute of Medical Education and Research
Chandigarh CHANDIGARH 160012 India |
| Phone |
9914492255 |
| Fax |
|
| Email |
Narayanairrinki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Medical Education and Research, Chandigarh, India, PIN CODE:160012 |
|
|
Primary Sponsor
|
| Name |
Nikesh Jaiswal |
| Address |
General Surgery Department,Post-Graduate Institute of Medical Education and Research, India, PIN CODE:160012 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Nikesh Jaiswal |
Post-Graduate Institute of Medical Education and Research |
Room no 6, General Surgery Department,Sector-12, Chandigarh Chandigarh CHANDIGARH |
8235919557
jaiswalnikesh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Oral capecitabine
|
1. Oral capecitabine will be given 1250 mg/sq. m. twice a day on days 1-14 of a 3 weekly cycle for 6 cycles.
|
| Comparator Agent |
IV Gemcitabine and oxaliplatin |
Patients will receive IV Gemcitabine and IV Oxaliplatin at a standard dose schedule. IV Gemcitabine will be given 1000 mg/sq. m. each administered on days 1 and 8, every 3 weeks for 6 cycles. IV Oxaliplatin will be given 130 mg/sq. m. on day 1, every 3 weeks for 6 cycles.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Patients with diagnosis of primarily metastatic gall bladder cancer to Liver and, lymph nodal metastasis(Aorto-caval, para-aortic, celiac) based on preoperative or intraoperative evidence without prior chemoradiotherapy for GBC
ECOG Performance status= 2
Total Bilirubin = 3 mg/dl(with/without biliary drainage)
|
|
| ExclusionCriteria |
| Details |
Patients refusing consent for participation in study
Pregnant and Lactating females
History of another major cancer or previous chemoradiotherapy
History or Cytology suggesting and alternate diagnosis other than adenocarcinoma
Gallbladder cancer with isolated peritoneal metastasis, extrahepatic biliary obstruction, extra-abdominal metastasis and metastatic incidental GBC
Patients with evidence of active infections or chronic diarrhea
Known case of chronic kidney disease, chronic liver disease, congestive heart failure.
Patients with poor performance score (ECOG greater than 2) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related quality of life among patients of unresectable/metastatic carcinoma gall bladder patients receiving CAPECITABINE v/s Gemcitabine and oxaliplatin |
Baseline, at the end of 3rd cycle, at the end of 6th cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of complications among two groups(CAPECITABINE v/s Gemox)
2. Compare the tolerability in each group
3. Compare the response to chemotherapy in terms of progression free survival & overall survival |
At baseline, at the end of 3rd cycle, at the end of 5th cycle |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
25/02/2025 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with history and clinical examination suggestive of gall bladder carcinoma will be evaluated as per the NCCN guidelines 2018. Preoperatively patients will be evaluated using abdominal ultrasonography and cross sectional imaging in the form of a FDG PET CT. The staging of gall bladder carcinoma will be done according to AJCC 8th edition. All the patients with resectable Gall Bladder Cancer/locally advanced gall bladder carcinoma with feasibility for surgery will be excluded from the study. The patients with unresectable/metastatic gall bladder carcinoma will be evaluated further with detailed history, physical examination, biochemical evaluation and necessary radiological evaluation as per the standard care. The patients with total bilirubin less than 3 mg/dl with/without biliary drainage will be included in the study. All patients with unresectable metastatic carcinoma gall bladder as per the inclusion and exclusion criteria mentioned previously will be explained regarding the trial protocol and the chemotherapy regimen that is going to be administered using patient information sheets printed in English, hindi and Punjabi. A written informed consent will be taken from all the participants of the study before randomization. The patients will be informed about the chemotherapy regimen they are going to receive before randomization and a baseline Quality of life score using EORTC QLQ-C30 would be recorded before randomization. Patients will be randomized between two groups; one group receiving oral capecitabine as mentioned later as Group A and another group receiving injectable gemcitabine and oxaliplatin as mentioned later as Group B. A total of 6 cycles would be administered. Quality of life would be recorded at the end of every cycle. Change in quality of life score will be compared at baseline, 3rd cycle and end of chemotherapy. The response to chemotherapy would be measured using PET CT and PERCIST criteria as Complete Metabolic Response, Partial Metabolic Response, Stable Metabolic Disease, Progressive Metabolic Disease at the end of 3rd cycle, 6th cycle and 3 months after completion of chemotherapy.At the end of 3rdcycle, Patients with Progressive metabolic disease will not receive further treatment while patients with complete metabolic response, partial metabolic response and stable disease will receive further chemotherapy. The number of chemotherapy cycles tolerated would be measured and compliance to the chemotherapy would be measured at the end of every cycle. |