Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research