Tomotherapy In Locally Advanced Gallbladder And Pancreatic Cancers

Study Overview

Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

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.

Pancreatic Neoplasms Malignant
Malignant Neoplasm of Gall Bladder Non-resectable

RADIATION: Tomotherapy

IRB 599

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-05-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-08-05
First Submitted that Met QC Criteria 2010-05-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-08-07
First Posted (ESTIMATED) 2010-05-07	Results First Posted N/A	Last Verified 2010-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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	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

Participant Group/Arm

Intervention/Treatment

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

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

Primary Outcome Measures	Measure Description	Time Frame
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers	Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability	3 Years

Secondary Outcome Measures	Measure Description	Time Frame
Response to CTRT	All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT	3 months
R0 resection rate	All patients will be jointly evaluated for surgery 6 weeks post chemoradiation	6 weeks
Locoregional control		3 years
Overall survival	At the median follow up of 3 years the 5 year overall survival rate would be assesed	3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Reena Engineer, MD, Tata Memorial Centre

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record