Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

NCT02778308 | Completed DMC

• 1 other identifier: FI/IEC/MAMC(32)/4/2012/239
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Cancer

Keywords

Gallbladder cancer, adjuvant chemotherapy, gemcitabine

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

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

  From date of randomization until the date of first documented recurrence, assessed up to 100 months.

Secondary Outcomes (3)

• Overall Survival

  From date of randomization until the date of death from any cause, assessed up to 100 months

• Blood and lymphatic system Adverse events

  till 6 weeks after last cycle

• Gastrointestinal system Adverse events

  Till 6 weeks after last cycle

Study Arms (2)

chemotherapy group

ACTIVE COMPARATOR

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

Drug: Gemcitabine + Cisplatin

control group

NO INTERVENTION

follow up

Interventions

Gemcitabine + Cisplatin DRUG

Day 1 and day 8 Gemcitabine Day 1 cisplatin

Also known as: GemCis

chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• T1a tumors
• Patients with metastatic disease
• Patients unfit to undergo chemotherapy
• Patients unwilling to undergo the trial
• Patients with double cancers

Sponsors & Collaborators

• Govind Ballabh Pant Institute of Postgraduate Medical Education and Research: lead

Study Sites (1)

GIPMER

New Delhi, 110002, India

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 3968886 BACKGROUND

• 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.

  PMID: 7059239 BACKGROUND

• 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.

  PMID: 14993027 BACKGROUND

• 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.

  PMID: 8916879 BACKGROUND

• 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.

  PMID: 20375404 BACKGROUND

• 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.

  PMID: 12365016 BACKGROUND

• 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.

  PMID: 34545545 DERIVED

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Pramod K Mishra, Phd

  GIPMER

  STUDY CHAIR

• Kishore Singh, MD

  Lok Nayak Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: May 19, 2016
• Study Start: January 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)