Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Recruitment status was Recruiting
PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase feasibility study
Primary To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.
- To study clinical benefit response
- To assess the acute and late toxicities associated with this treatment
- To assess radiologic and metabolic response to treatment.
- To assess the resectability rate with microscopic negative margin (R0).
- To study the locoregional control and progression free survival (PFS).
- To measure the Quality of life (QOL) scores.
DESIGN: Feasibility 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
Gallbladder Neoplasms and Pancreatic Neoplasms
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Feasibility Study|
- To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
- Response to CTRT [ Time Frame: 3 months ] [ Designated as safety issue: No ]All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118897
|Contact: Reena Engineer, MDfirstname.lastname@example.org|
|Contact: ShyamKishore Shrivastava, MDemail@example.com|
|Tata Memorial Centre||Recruiting|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Reena Engineer, MD||Tata Memorial Centre|