Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

Gallbladder Cancer Clinical Trial

Official title:

Randomized Controlled Trial Comparing Adjuvant Chemotherapy Vs. no Chemotherapy for Patients With Carcinoma of Gallbladder Undergoing Curative Resection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778308
• Other study ID #: FI/IEC/MAMC(32)/4/2012/239
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2018

Study information

• Verified date: April 2021
• Source: Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gallbladder Cancer
• Gallbladder Neoplasms

Intervention

Drug:
• Gemcitabine + Cisplatin
Day 1 and day 8 Gemcitabine Day 1 cisplatin

Locations

Country	Name	City	State
India	GIPMER	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (7)

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.

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. Review. — View Citation

Hamrick RE Jr, Liner FJ, Hastings PR, Cohn I Jr. Primary carcinoma of the gallbladder. Ann Surg. 1982 Mar;195(3):270-3. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	Defined as the time interval between the date of randomization and death from disease or unrelated cause	From date of randomization until the date of death from any cause, assessed up to 100 months
Secondary	Blood and lymphatic system Adverse events	As per CTCAE version 5 criteria	till 6 weeks after last cycle
Secondary	Gastrointestinal system Adverse events	As per CTCAE version 5 criteria	Till 6 weeks after last cycle