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


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Gallbladder Neoplasms and Pancreatic Neoplasms

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability

Outcome Time Frame:

3 Years

Safety Issue:

Yes

Principal Investigator

Reena Engineer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Centre

Authority:

India: Institutional Review Board

Study ID:

IRB 599

NCT ID:

NCT01118897

Start Date:

December 2008

Completion Date:

January 2013

Related Keywords:

  • Gallbladder Neoplasms and Pancreatic Neoplasms
  • Gall bladder
  • Pancreatic cancers
  • Tomotherapy
  • Neoplasms
  • Gallbladder Neoplasms
  • Pancreatic Neoplasms

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