Clinical Trial: Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study
Brief Summary:
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
- To assess the resectability rate with microscopic negative margin (R0).
- To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
- To study the locoregional control in the patients undergoing R0 resection
- 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:
Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Response to CTRT [ Time Frame: 3 months ]All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT
- R0 resection rate [ Time Frame: 6 weeks ]All patients will be jointly evaluated for surgery 6 weeks post chemoradiation
- Locoregional control [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]At the median follow up of 3 years the 5 year overall survival rate would be assesed
Original Secondary Outcome: Response to CTRT [ Time Frame: 3 months ]
Information By: Tata Memorial Hospital
Dates:
Date Received: May 3, 2010
Date Started: December 2008
Date Completion:
Last Updated: August 5, 2015
Last Verified: May 2010