Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reena Engineer, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01118897
First received: May 3, 2010
Last updated: August 5, 2015
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Pancreatic Neoplasms Malignant
Malignant Neoplasm of Gall Bladder Non-resectable
Radiation: Tomotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability


Secondary Outcome Measures:
  • Response to CTRT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT

  • R0 resection rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    All patients will be jointly evaluated for surgery 6 weeks post chemoradiation

  • Locoregional control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    At the median follow up of 3 years the 5 year overall survival rate would be assesed


Enrollment: 60
Study Start Date: December 2008
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Radiation: 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118897

Locations
India
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Reena Engineer, MD Tata Memorial Centre
  More Information

No publications provided

Responsible Party: Reena Engineer, Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01118897     History of Changes
Other Study ID Numbers: IRB 599
Study First Received: May 3, 2010
Last Updated: August 5, 2015
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
Gall bladder
Pancreatic cancers
Tomotherapy

Additional relevant MeSH terms:
Gallbladder Neoplasms
Neoplasms
Pancreatic Neoplasms
Biliary Tract Diseases
Biliary Tract Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gallbladder Diseases
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on August 31, 2015