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NCT Number: NCT02778308

Adjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GIPMER

New Delhi, 110002, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gemcitabine + Cisplatin

Drug

Day 1 and day 8 Gemcitabine Day 1 cisplatin

Other names: GemCis

Primary outcomes

  1. Disease Free Survival

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

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

Secondary outcomes

  1. Overall Survival

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

    Defined as the time interval between the date of randomization and death from disease or unrelated cause

  2. Blood and lymphatic system Adverse events

    Time frame: till 6 weeks after last cycle

    As per CTCAE version 5 criteria

  3. Gastrointestinal system Adverse events

    Time frame: Till 6 weeks after last cycle

    As per CTCAE version 5 criteria

Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Institute of Postgraduate Medical Education and Research

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
May 19, 2016
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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