Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
|ClinicalTrials.gov Identifier: NCT01118897|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : August 7, 2015
PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study
Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.
- 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.
Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms Malignant Malignant Neoplasm of Gall Bladder Non-resectable||Radiation: Tomotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study|
|Study Start Date :||December 2008|
|Primary Completion Date :||January 2013|
|Study Completion Date :||June 2013|
Experimental: Neoadjuvant chemoradiation
All patients will receive concurrent chemoradiation. Chemotherapy will consist of Inj. Gemcitabine 300mg/mt2 weekly throughout the course of Radiotherapy. Radiotherapy will be delivered using Tomotherapy to a dose of 57Gy/25# over 5 weeks
Radiotherapy 57-60 Gy in 25 fraction to PTV boost (SIBV - simultaneous integrated Boost volume) (2.3-2.4Gy/Fr)
Concurrent chemotherapy Weekly concurrent CT schedule: Inj Gemcitabine 300 mg/m2 weekly during RT.
Surgery: All patients will be evaluated for surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy.
- To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers [ Time Frame: 3 Years ]Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118897
|Tata Memorial Centre|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Reena Engineer, MD||Tata Memorial Centre|