Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Condition: Pancreatic Neoplasms Malignant; Malignant Neoplasm of Gall Bladder Non-resectable
MeSH terms: Neoplasms; Pancreatic Neoplasms; Gallbladder Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Tomotherapy
Intervention type(s): Radiation
Intervention description(s): 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 model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gall bladder; Pancreatic cancers; Tomotherapy