Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
• Treatments: Cisplatin; Gemcitabine

Criteria

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