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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 Total Bilirubin  
 
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.

 
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