Malignant Neoplasm of Gall Bladder Non-resectable Clinical Trial
Official title:
Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study
| Verified date | May 2010 |
| Source | Tata Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Institutional Review Board |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | June 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Tata Memorial Centre | Mumbai | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Tata Memorial Hospital |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Response to CTRT | All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT | 3 months | No |
| Secondary | R0 resection rate | All patients will be jointly evaluated for surgery 6 weeks post chemoradiation | 6 weeks | No |
| Secondary | Locoregional control | 3 years | No | |
| Secondary | Overall survival | At the median follow up of 3 years the 5 year overall survival rate would be assesed | 3 years | No |