Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma
Condition: Gallbladder Cancer
MeSH terms: Gallbladder Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Gemcitabine + Cisplatin
Intervention type(s): Drug
Intervention description(s): Day 1 and day 8 Gemcitabine Day 1 cisplatin
Other intervention name(s): GemCis
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gallbladder cancer, adjuvant chemotherapy, gemcitabine