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Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

Primary Purpose

Gallbladder Cancer

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Gemcitabine + Cisplatin
Sponsored by
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Cancer focused on measuring Gallbladder cancer, adjuvant chemotherapy, gemcitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. T1b and above adenocarcinoma of gall bladder
  2. Patients undergoing curative resection
  3. Incidentally diagnosed carcinoma who have undergone curative completion radical cholecystectomy

Exclusion Criteria:

  1. T1a tumors
  2. Patients with metastatic disease
  3. Patients unfit to undergo chemotherapy
  4. Patients unwilling to undergo the trial
  5. Patients with double cancers

Sites / Locations

  • GIPMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

chemotherapy group

control group

Arm Description

6 cycles of Gemcitabine + Cisplatin as per the following schedule Injection Gemcitabine 1 gm/kgm2 intravenous over 30 min Day1 and Day8 Injection Cisplatin 70 mg/m2 intravenous on Day1

follow up

Outcomes

Primary Outcome Measures

Disease Free Survival
Defined as the time interval between the date of randomization and the date of disease recurrence.

Secondary Outcome Measures

Overall Survival
Defined as the time interval between the date of randomization and death from disease or unrelated cause
Blood and lymphatic system Adverse events
As per CTCAE version 5 criteria
Gastrointestinal system Adverse events
As per CTCAE version 5 criteria

Full Information

First Posted
March 6, 2016
Last Updated
April 2, 2021
Sponsor
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02778308
Brief Title
Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma
Official Title
Randomized Controlled Trial Comparing Adjuvant Chemotherapy Vs. no Chemotherapy for Patients With Carcinoma of Gallbladder Undergoing Curative Resection.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. Higher incidence has been noted in Chile, Mexico and Southwest American Indians.[1] It is the third most common malignancy in India.[2] The disease may mimic benign disease in presentation.Up to 1/3rd of patients may present with jaundice but of these only 7% will be resectable.[4] With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease and 63% for stage III have been reported.[5] Treatment of choice is complete surgical resection. The role of chemotherapy and radiotherapy is not very well documented in treatment of gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant chemotherapy or chemo-radiotherapy seems a rational therapeutic option. Gemcitabine with or without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin was found to be more effective than gemcitabine alone and provides definite survival advantage and progression free survival.[6] An earlier randomized trial done to assess the efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement in disease free and overall 5 year survival.[7] But this study has included patients with suboptimal resection and all pancreato-biliary malignancy. In view of these observations this study is being designed to assess the efficacy of the chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone curative resections.
Detailed Description
Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. United states has an incidence of 1/100000.Higher incidence has been noted in Chile, Mexico and Southwest American Indians. It is the third most common malignancy in India. The disease may mimic benign disease in presentation. Now 78-85% of the cases may be detected preoperatively with radiological imaging. 1-3% of the carcinoma of the gall bladder may be detected incidentally. Up to 1/3rd of patients may present with jaundice but of these only 7% will be resectable. With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease and 63% for stage III have been reported. Treatment of choice is complete surgical resection. The role of chemotherapy and radiotherapy is not very well documented in treatment of gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant chemotherapy or chemo-radiotherapy seems a rational therapeutic option. The chemotherapies are based on 5 Fluorouracil with or without radiotherapy. Gemcitabine with or without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin was found to be more effective than gemcitabine alone and provides definite survival advantage and progression free survival. An earlier randomized trial done to assess the efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement in disease free and overall 5 year survival. But this study has included patients with suboptimal resection and all pancreato-biliary malignancy. In view of these observations this study is being designed to assess the efficacy of the chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone curative resections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Cancer
Keywords
Gallbladder cancer, adjuvant chemotherapy, gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy group
Arm Type
Active Comparator
Arm Description
6 cycles of Gemcitabine + Cisplatin as per the following schedule Injection Gemcitabine 1 gm/kgm2 intravenous over 30 min Day1 and Day8 Injection Cisplatin 70 mg/m2 intravenous on Day1
Arm Title
control group
Arm Type
No Intervention
Arm Description
follow up
Intervention Type
Drug
Intervention Name(s)
Gemcitabine + Cisplatin
Other Intervention Name(s)
GemCis
Intervention Description
Day 1 and day 8 Gemcitabine Day 1 cisplatin
Primary Outcome Measure Information:
Title
Disease Free Survival
Description
Defined as the time interval between the date of randomization and the date of disease recurrence.
Time Frame
From date of randomization until the date of first documented recurrence, assessed up to 100 months.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Defined as the time interval between the date of randomization and death from disease or unrelated cause
Time Frame
From date of randomization until the date of death from any cause, assessed up to 100 months
Title
Blood and lymphatic system Adverse events
Description
As per CTCAE version 5 criteria
Time Frame
till 6 weeks after last cycle
Title
Gastrointestinal system Adverse events
Description
As per CTCAE version 5 criteria
Time Frame
Till 6 weeks after last cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: T1b and above adenocarcinoma of gall bladder Patients undergoing curative resection Incidentally diagnosed carcinoma who have undergone curative completion radical cholecystectomy Exclusion Criteria: T1a tumors Patients with metastatic disease Patients unfit to undergo chemotherapy Patients unwilling to undergo the trial Patients with double cancers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pramod K Mishra, Phd
Organizational Affiliation
GIPMER
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kishore Singh, MD
Organizational Affiliation
Lok Nayak Hospital
Official's Role
Study Director
Facility Information:
Facility Name
GIPMER
City
New Delhi
ZIP/Postal Code
110002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
1. Perkin DM, Whelan SL, Ferlay J, Raymond L, Young J. Cancer incidence in five continents. Vol VII, Lyon, France: International Agency for Research on Cancer Scientific Publication No. 143, 1997.
Results Reference
background
PubMed Identifier
3968886
Citation
Shukla VK, Khandelwal C, Roy SK, Vaidya MP. Primary carcinoma of the gall bladder: a review of a 16-year period at the University Hospital. J Surg Oncol. 1985 Jan;28(1):32-5. doi: 10.1002/jso.2930280109.
Results Reference
background
PubMed Identifier
7059239
Citation
Hamrick RE Jr, Liner FJ, Hastings PR, Cohn I Jr. Primary carcinoma of the gallbladder. Ann Surg. 1982 Mar;195(3):270-3. doi: 10.1097/00000658-198203000-00005.
Results Reference
background
PubMed Identifier
14993027
Citation
Hawkins WG, DeMatteo RP, Jarnagin WR, Ben-Porat L, Blumgart LH, Fong Y. Jaundice predicts advanced disease and early mortality in patients with gallbladder cancer. Ann Surg Oncol. 2004 Mar;11(3):310-5. doi: 10.1245/aso.2004.03.011.
Results Reference
background
PubMed Identifier
8916879
Citation
Bartlett DL, Fong Y, Fortner JG, Brennan MF, Blumgart LH. Long-term results after resection for gallbladder cancer. Implications for staging and management. Ann Surg. 1996 Nov;224(5):639-46. doi: 10.1097/00000658-199611000-00008.
Results Reference
background
PubMed Identifier
20375404
Citation
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
Results Reference
background
PubMed Identifier
12365016
Citation
Takada T, Amano H, Yasuda H, Nimura Y, Matsushiro T, Kato H, Nagakawa T, Nakayama T; Study Group of Surgical Adjuvant Therapy for Carcinomas of the Pancreas and Biliary Tract. Is postoperative adjuvant chemotherapy useful for gallbladder carcinoma? A phase III multicenter prospective randomized controlled trial in patients with resected pancreaticobiliary carcinoma. Cancer. 2002 Oct 15;95(8):1685-95. doi: 10.1002/cncr.10831.
Results Reference
background
PubMed Identifier
34545545
Citation
Saluja SS, Nekarakanti PK, Mishra PK, Srivastava A, Singh K. Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection. J Gastrointest Surg. 2022 Feb;26(2):398-407. doi: 10.1007/s11605-021-05143-6. Epub 2021 Sep 20.
Results Reference
derived

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Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

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