Malignant Neoplasm of Gall Bladder Non-resectable Clinical Trial
Official title:
Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study
SUMMARY
PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced
Gallbladder and Pancreatic cancers: A Phase II study
SPECIFIC OBJECTIVES:
Primary To assess the radiological response by dose escalated IMRT in locally advanced
inoperable gallbladder and pancreatic cancers.
Secondary
1. To assess the resectability rate with microscopic negative margin (R0).
2. To assess the acute and late toxicities (Number of Participants with Adverse Events as
a Measure of Safety and Tolerability)
3. To study the locoregional control in the patients undergoing R0 resection
4. To study overall survival
DESIGN: Phase II study
STUDY POPULATION: All patients of age >18 years years diagnosed with non metastatic locally
advanced inoperable gall bladder and pancreatic cancer
STUDY SIZE: 60 patients
METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the
informed consent.
Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy
Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if
operable will undergo surgery, if still inoperable or metastatic will receive palliative
chemotherapy.
PROJECT PERIOD:
Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of
data : 1 year
STUDY SITE: Tata memorial centre
In both gall bladder and pancreatic cancer surgery is the main stay of treatment, but majority of these tumors are inoperable by virtue of adjacent organ infiltration. In this study, inoperable gallbladder and pancreatic cancer patients will be treated with high precision radiotherapy using Tomotherapy delivering higher dose of radiation along with chemotherapy. It is expected that this high dose precise radiotherapy along with chemotherapy will lead to good symptom relief and make some of these tumors operable. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment