| CTRI Number |
CTRI/2024/08/072162 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Perioperative Gemcitabine based chemotherapy vs surgery and adjuvant CAPECITABINE and chemo-radiation in operable GBC |
|
Scientific Title of Study
|
Perioperative Gemcitabine based chemotherapy versus upfront resection followed by adjuvant
capecitabine with and chemo-radiation in operable Stage III Gall bladder cancers (GBC) –
A Randomised, open-label, Two-Arm phase III Prospective Clinical Trial |
| Trial Acronym |
GB-GeCCOR II |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Ostwal |
| Designation |
Professor and consultant Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Department of Medical Oncology GI, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Ostwal |
| Designation |
Professor and consultant Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Department of Medical Oncology GI, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Ostwal |
| Designation |
Professor and consultant Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room number 1102,Department of Medical Oncology GI, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702288801 |
| Fax |
|
| Email |
dr.vikas.ostwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| We will request for Drug support and extramural grant from pharma companies and we will request for intramural fund from Tata Memorial Hospital, Mumbai
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai Maharashtra India 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vikas Ostwal |
Tata Memorial Hospital |
OPD 319, Dept of GI Medical Oncology, 3rd floor, Homi Bhabha Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9702288801
dr.vikas.ostwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
| Institutional Ethics Committee- II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CAPECITABINE (adjuvant therapy) |
Patients in this arm will undergo upfront resection followed by
adjuvant CAPECITABINE
CAPECITABINE1000 mg per meter square twice daily for 2 weeks followed by 1 week of rest |
| Intervention |
Surgery plus chemotherapy Gmecitabine Cisplatin and Nab paclitaxel |
Neoadjuvant and Adjuvant chemotherapy Gemcitabine Cisplatin and Nab Paclitaxel. Surgery will be sandwiched between neoadjuvant and adjuvant chemotherapy.
Gemcitabine 800 mg per meter squares plus
Nab-paclitaxel 100 mg per meter squares plus
Cisplatin 25 mg per meter squares(GCNabP)
D1 and D8 every 21 days
1 cycle of 21 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Histologically confirmed adenocarcinoma (FNAC or biopsy) of the
gallbladder
2.No radiological or clinical evidence of metastatic disease and no
evidence of metastatic disease as discovered by on-table evaluation
during definitive surgery
3.Patients presenting with pT3 or/and pN + disease after simple
cholecystectomies who are non-metastatic and still resectable
4.The patients who present with upfront cT3 and or cN+ disease and are
non-metastatic and resectable
5.The patients who present with upfront cT2 and cN+ disease and are
non-metastatic and resectable
6.Operable disease decided in MDT
7.ECOG performance status 0 - 1
8.Patient does not have any contraindications to receive chemotherapy
9.Adequate hematological, hepatic and renal function parameters -
hematological- Hb greater than 80 g/L, ANC greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L.
Liver functions- bilirubin lesser than or equal to 2 x upper limit normal (ULN),
AST/ALT lesser than or equal to 5 x ULN, S. albumin greater than or equal to 2.8 g/L
10.Renal function- Creatinine lesser than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 50 mL/min.
11.Women of childbearing age should have a negative pregnancy test at
the time of randomization and should be willing to use adequate
contraception during the treatment phase of the trial. |
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity or contraindications against gemcitabine,
cisplatin, Nab-Paclitaxel or CAPECITABINE or radiation therapy.
2.Radiological T1 patients will not be included if radiologists are sure
about the cT1 at presentation
3.Clinically significant active coronary heart disease, cardiomyopathy,
valvular heart disease or congestive heart failure, NYHA III-IV,
4.Past or current history of other malignancies not curatively treated and
without evidence of disease for more than 5 years, except for
curatively treated basal cell carcinoma of the skin and in situ
carcinoma of the cervix
5.Other severe internal disease or acute infection
6.Subject pregnant or breast feeding, or planning to become pregnant
within 6 months after the end of treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin-
nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by
surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral
CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers. |
To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin-
nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by
surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral
CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers.
Assessments will be done at baseline and after every 4 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate difference in DFS at 36 months between perioperative gemcitabine-cisplatin-
nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed
by surgery & adjuvant gemcitabine-cisplatin) & upfront surgery & adjuvant oral
CAPECITABINE for in operable Gall BladderCancers.
1.To assess the QOL of these patients in each of these arms.
2.To evaluate differences in R0 resection rates between the two arms
3.To evaluate differences in resection rates between the two arms
4.To evaluate differences in treatment completion rates between the two arms
5.To evaluate differences in treatment related adverse event profiles between the two arms |
36 months |
|
|
Target Sample Size
|
Total Sample Size="294"
Sample Size from India="294"
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 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="7"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Short
title : Perioperative Gemcitabine based chemotherapy vs
surgery and adjuvant capecitabine with chemoradiation in operable GBC
Indication
Patients
with operable gallbladder cancer to find out whether the addition of
chemotherapy before the surgery improves the survival.
Type of study
Randomized,
open label phase III clinical trial
Study design
Patients
with operable Gall Bladder Cancer will undergo randomization into one of two
arms
Arm A (Perioperative Arm)
Patients
will receive perioperative therapy in this arm - Surgery will be sandwiched
between chemotherapy before and after surgery in this arm.
Gemcitabine
(G) 800mg/m2 plus Nab-paclitaxel (NabP) 100mg/m2 plus Cisplatin (C) 25mg/m2
(GCNabP)
D1, D8,
q 21 days
1 cycle
= 21 days
Patient
will receive 2-4 cycles of GCNabP followed by assessment for surgery.
Post-surgery, patient will receive 2-4 cycles of GC. Patient will be planned
for a total of 6 to 8 cycles of chemotherapy perioperatively.
Arm B –(Surgery followed by Capecitabine and
capecitabine radiation concurrently)
Patient
will undergo upfront surgery in this arm, followed by adjuvant oral
chemotherapy.
Surgery→
Capecitabine
6 #
And
capecitabine plus radiation
Sample
size
294
patients
Study
duration
7 years
|