NCT01118897

Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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

Detailed description

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.

Conditions

• Pancreatic Neoplasms Malignant
• Malignant Neoplasm of Gall Bladder Non-resectable

Interventions

Type	Name	Description
RADIATION	Tomotherapy	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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-01-01
• Completion: 2013-06-01
• First posted: 2010-05-07
• Last updated: 2015-08-07

Locations

1 site across 1 country: India