| CTRI Number |
CTRI/2024/01/061479 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of prolongation of life with 2 different chemotherapy regimens - Gemcitabine – Cisplatin – Nab-Paclitaxel (GAP) and gemcitabine-platinum (GP) combination in advanced gallbladder cancers. |
|
Scientific Title of Study
|
Gemcitabine-cisplatin-albumin bound paclitaxel (GAP) versus gemcitabine-platinum (GP) in advanced gallbladder cancers (GBC) - a randomized parallel design phase III clinical trial (GAP-GB) |
| Trial Acronym |
GAP-GB STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anant Ramaswamy |
| Designation |
Professor Medical oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
1102, 11th Floor, Department of Medical Oncology GI Homi Bhabha Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833034802 |
| Fax |
|
| Email |
anantr13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anant Ramaswamy |
| Designation |
Professor Medical oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
1102, 11th Floor, Department of Medical Oncology GI, Homi Bhabha Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833034802 |
| Fax |
|
| Email |
anantr13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anant Ramaswamy |
| Designation |
Professor Medical oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
1102, 11th Floor, Department of Medical Oncology GI, Homi Bhabha Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833034802 |
| Fax |
|
| Email |
anantr13@gmail.com |
|
|
Source of Monetary or Material Support
|
| The study drugs are of standard of care available at the pharmacy of Tata Memorial Hospital Mumbai. |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital,Dr Ernest Borges Road, Parel, Mumbai 400012, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
NOT Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vamshi Krishna |
Asian Institute of Gastroenterology (AIG) |
Asian Institute of Gastroenterology (AIG)
Survey No 136, 4/5, Plot No 2/3, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
9959778112
dr.vamshik@aighospitals.com |
| Dr Anuj Gupta |
Dr. Anuj Gupta |
OPD No.33 Ground floor DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi (U.P.) 221005 India.
Varanasi
UTTAR PRADESH |
9588229594
dr.anuj.gupta24@gmail.com |
| Dr Alok Goel |
Homi Bhabha Cancer Hospital (HBCH) and Research Centre Punjab |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center), Medicity, Plot no.1, New Chandigarh, Punjab 140901
Chandigarh
CHANDIGARH |
9899701286
alokdrgoel@gmail.com |
| Dr Gunjesh Kumar Singh |
Paras HEC Hospital, Ranchi. |
Paras HEC Hospital, Near Prabhat Tara School, Khataal, Dhurwa, Ranchi, Jharkhand 834004
Ranchi
JHARKHAND |
9650564838
gunjeshsingh00764@gmail.com |
| Dr Anant Ramaswamy |
Tata Memorial Hospital |
OPD Room number 319, 3rd floor,Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9833034802
anantr13@gmail.com |
| Dr Soumya Surath Panda |
The Institute of Medical Sciences and Sum Hospital |
The Institute of Medical Sciences and Sum Hospital
Ground Floor, Sum Hospital Rd, Shampur, Bhubaneswar, Odisha 751003
Sambalpur
ORISSA |
8895370579
ssp_scb@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee HBCH And RC Mullanpur |
Approved |
| Institutional Ethics Committee IEC AIG |
Approved |
| Institutional Ethics Committee IMS and SUM Hospitals |
Approved |
| Institutional ethics committee MPMMCC Varanasi |
Approved |
| Institutional Ethics Committee TMH |
Approved |
| KASHYAP MEMORIAL EYE HOSPITAL ETIDCS COMMIITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gemcitabine and Cisplatin and nab paclitaxel |
The intravenous intervention will be administer to the patients until disease progression or unacceptable severe toxicity.
Nab Paclitaxel 100 mg per m2 IV over 30 mins on D1 and D8 plus Gemcitabine 1000mg per m2 IV over 30 mins D1 and D8 plus Cisplatin 25 mg per m2 IV over 60 minutes D1 and D8
Start of next cycle on D22
Three weekly cycles will be allowed till a maximum of 8 cycles.After 8 cycles assuming the patient has clinical or radiological response or disease stabilization,treating physicians will be allowed to treat further with the following options
1.Observation and treat when and if there is disease progression
2.Gemcitabine monotherapy once every 2 weeks
3.Gemcitabine and cisplatin as below |
| Comparator Agent |
Gemcitabine and platinum based chemotherapy |
Three treatment regimens will be allowed in Arm B
1.Gemcitabine and cisplatin
Gemcitabine 1000 mg per m2 IV over 30 mins,D1 and D8 plus Cisplatin 25 mg per m2 IV over 60 minutes D1 and D8
Start of next cycle on D22
Three weekly cycles will be allowed till a maximum of 8 cycles.After 8 cycles, assuming the patient has clinical or radiological response or disease stabilization treating physicians will be allowed to treat further with the following options
i. Observation and treat when and if there is disease progression
ii. Gemcitabine monotherapy once every 2 weeks till disease progression or tolerance
iii. Gemcitabine and cisplatin (as below) till disease progression or tolerance
2.Gemcitabine and Oxaliplatin
Gemcitabine 1000mg per m2 IV over 30 mins,D1 Oxaliplatin 100 mg per m2 IV over 60 minutes D1
Start of next cycle on D15
Two weekly cycles will be allowed till a maximum of 12 cycles.After 12 cycles, assuming the patient has clinical or radiological response or disease stabilization, treating physicians will be allowed to treat further with the following options
i.Observation and treat when and if there is disease progression
ii.Gemcitabine monotherapy - once every 2 weeks till disease progression or tolerance
3.Gemcitabine and Carboplatin
Gemcitabine 1000 mg per m2 IV over 30 mins D1 and D8 plus Carboplatin AUC 5 or AUC 6 IV over 60 to 180 minutes D1
Start of next cycle on D22
Three weekly cycles will be allowed till a maximum of 8 cycles. After 8 cycles, assuming the patient has clinical or radiological response or disease stabilization, treating physicians will be allowed to treat further with the following options
i. Observation and treat when and if there is disease progression
ii. Gemcitabine monotherapy - once every 2 weeks till disease progression or tolerance
iii. Gemcitabine and Carboplatin till disease progression or tolerance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Histologically confirmed adenocarcinoma of the gallbladder with the following specifications
1. Locally advanced unresectable or metastatic on radiology
2. Age more than 18 years
3. ECOG performance status 0-2
4. Patient who can give informed consent for the study.
5. Patient does not have any contraindications to receive chemotherapy
6. Adequate Hematological, hepatic and renal function parameters
7. ECG within acceptable limits
8. 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. Distal cholangiocarcinoma,intrahepatic or perihilar cholangiocarcinomas
2. Known hypersensitivity or contraindications against gemcitabine, cisplatin, oxaliplatin,albumin bound paclitaxel and carboplatin
3. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure,NYHA III to IV, clinically significant valvular defect
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. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
6. Other severe internal disease or acute infection
7. Baseline neuropathy more than NCI Grade I
8. Chronic inflammatory bowel disease
9. On treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
10. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
11. Patients who have completed adjuvant Gem or Platinum based chemotherapy within 6 months.
12. Received any prior chemotherapy or radiotherapy or cancer directed therapy within the last 5 years (excepting as adjuvant therapy as indicated prior)
13. Any active ILD or history of lung illness requiring bronchodilator drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint of the study is to compare the overall survival (OS) of the GAP regimen to Gemcitabine platinum combination. |
The study duration is of 48 months.
Total around 350 patients will be screened and 255 eligible patients shall be included in this study over 36 months period.Patients will be followed for 12 months.
Response assessment scans will be performed at baseline and after every 4 cycles.
QOL analysis will be conducted at the following time intervals (approximate) at Baseline
At approximately 3 months and 6 months post starting therapy.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary endpoints The secondary endpoints and objectives include
1. To compare the progression free survival (PFS) of the GAP regimen to Gemcitabine platinum combination.
2. To compare the toxicity of the GAP regimen to Gemcitabine platinum combination.
3. To compare the tolerance of the GAP regimen to Gemcitabine platinum combination.
4. To compare the quality of life of the GAP regimen to Gemcitabine platinum combination. |
The total study duration is of 48 months |
|
|
Target Sample Size
|
Total Sample Size="255"
Sample Size from India="255"
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)
|
19/01/2024 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Study
Title: Gemcitabine-cisplatin-albumin bound paclitaxel (GAP) versus
gemcitabine-platinum (GP) in advanced gallbladder cancers (GBC) - a randomized
parallel design phase III clinical trial (GAP-GB)
Indication:Advanced/metastatic
gallbladder cancer (GBC) fit for first line chemotherapy
Type
of study :
Randomized parallel design two-arm phase III open label
Total around 350 patients will be screened and 255
eligible patients shall be included in this study over 36 months ’period.
Patients will be followed for 12 months.
This study will assess the prolongation oflife with
2 different chemotherapy regimens, which are Gemcitabine – Cisplatin –
Nab-Paclitaxel (GAP) (3 drugs) and gemcitabine-platinum (GP) combination (2
drugs). Both the regimes are part of standard chemotherapy options in advanced
gallbladder cancers. Either of them can be used to treat advanced gallbladder
cancers. The side effect profiles of each regime are different. The aim is to
look at the superiority of the 3-drug combination against 2 drug combination
regimens in prolonging the life. So, this study will look at two standard
treatment options in terms of benefit vs. side effects.
The
Investigator or a person designated will collect informed consent from all
participants, before which the Investigator or co-investigator must inform each
participant of the objectives, benefits, risks, and requirements of the study.
Subjects fulfill all in-/exclusion criteria, having
provided written informed consent on the approved informed consent form are
eligible for participation in the study.
They would then be randomized in 1:1 ratio into either of the two arms
viz Arm A or Arm B.
The mentioned drug regimens in both arms will be
administered as follows:
Arm A
GAP regimen
Gemcitabine
(800 mg/m2 IV on day 1 and day 8) plus
Cisplatin
(25 mg/m2 IV on day 1 and day 8) plus
Nab
Paclitaxel (100 mg/ m2 IV on day 1 and day 8)
Chemotherapy will be repeated every 21 days and
considered as one cycle.
Arm B
GP regimens
In
Arm B, the patient will receive one of the 3 following chemotherapy treatments
1.Gemcitabine
(1000 mg/m2 IV on day 1 and day 8) plus
Cisplatin (25 mg/m2 IV on day 1 and day
8) plus
Every 3 weeks
2.Gemcitabine
(1000 mg/m2 IV on day 1 and day 8) plus
Carboplatin
(AUC 5/6 on day 1) plus
Every 3 weeks
3.Gemcitabine
(1000 mg/m2 IV on day 1) plus
Oxaliplatin (100 mg/m2 IV on day 1) plus
Every 2 weeks
Quality
of life analysis will also be conducted in the study.
For all patients, the cost of
standard testing and therapywill be borne by the patient. As both arms are
standard of care, the cost of serious adverse events and hospitalization of the
patients, will be borne by the patient.
This trial is an investigator-initiated
trial and will be conducted as per ICMR guidelines. Medical care will be
provided for any complications arising from treatment. There will be no
compensation provided in the study.
The
complete evaluation of results and compilation of statistics will be performed
6-12 months after the last patient has been entered into trial and all
follow-up formalities are completed. |