Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118897
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):
Reena Engineer, Tata Memorial Hospital

Brief Summary:


PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study


Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.


  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.


Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of data : 1 year

STUDY SITE: Tata memorial centre

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Response to CTRT [ Time Frame: 3 months ]
    All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT

  2. R0 resection rate [ Time Frame: 6 weeks ]
    All patients will be jointly evaluated for surgery 6 weeks post chemoradiation

  3. Locoregional control [ Time Frame: 3 years ]
  4. Overall survival [ Time Frame: 3 years ]
    At the median follow up of 3 years the 5 year overall survival rate would be assesed

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118897

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

Responsible Party: Reena Engineer, Professor, Tata Memorial Hospital Identifier: NCT01118897     History of Changes
Other Study ID Numbers: IRB 599
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: May 2010

Keywords provided by Reena Engineer, Tata Memorial Hospital:
Gall bladder
Pancreatic cancers

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