Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

NCT ID: NCT01118897

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-06-30

Brief Summary

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

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.

Conditions

Pancreatic Neoplasms Malignant; Malignant Neoplasm of Gall Bladder Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tomotherapy

Intervention Type: RADIATION

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 surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy.

Interventions

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 surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy.

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Reena Engineer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reena Engineer, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Centre

Locations

Tata Memorial Centre

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

IRB 599

Identifier Type: -

Identifier Source: org_study_id