Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Conditions
Gallbladder Neoplasms and Pancreatic Neoplasms
Conditions: official terms
Gallbladder Neoplasms - Pancreatic Neoplasms
Conditions: Keywords
Gall bladder, Pancreatic cancers, Tomotherapy
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Tomotherapy
Type: Radiation
Overall Status
Recruiting
Summary
SUMMARY

PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase feasibility study

SPECIFIC OBJECTIVES:

Primary To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.

Secondary

1. To study clinical benefit response

2. To assess the acute and late toxicities associated with this treatment

3. To assess radiologic and metabolic response to treatment.

4. To assess the resectability rate with microscopic negative margin (R0).

5. To study the locoregional control and progression free survival (PFS).

6. 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.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Inoperable locally advanced gall bladder and pancreatic cancer by virtue of vascular encasement of superior mesenteric artery (SMA), celiac artery, hepatic artery, portal vein (PV) or deep hilar invasion precluding R0 resection.

2. Biopsy proven adenocarcinoma

3. KPS >= 70

4. Age >18 years

5. Medically fit for chemotherapy

6. Normal hematological, renal and hepatic function (Serum Bilirubin<3mg/dl)

7. No prior history of treatment with radiation or chemotherapy.

8. Patient willing and reliable for follow-up.

Exclusion criteria

1. Any other malignancy in any site.

2. Expected survival < 3months.

3. Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)

4. Malignant ascitis.

5. Distant metastases by clinical examination or by imaging/whole bodyPET scan.
Location
Tata Memorial Centre
Mumbai, Maharashtra, India
Status: Recruiting
Start Date
December 2008
Completion Date
January 2013
Sponsors
Tata Memorial Hospital
Source
Tata Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page