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

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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.