Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Primary Purpose
Pancreatic Neoplasms Malignant, Malignant Neoplasm of Gall Bladder Non-resectable
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Tomotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms Malignant focused on measuring Gall bladder, Pancreatic cancers, Tomotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
- Biopsy proven adenocarcinoma
- KPS >= 70
- Age >18 years
- Medically fit for chemotherapy
- Normal hematological, renal and hepatic function (Serum Bilirubin<3mg/dl)
- No prior history of treatment with radiation or chemotherapy.
- Patient willing and reliable for follow-up.
Exclusion criteria
- Any other malignancy in any site.
- Expected survival < 3months.
- Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)
- Malignant ascitis.
- Distant metastases by clinical examination or by imaging/whole bodyPET scan.
Sites / Locations
- Tata Memorial Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant chemoradiation
Arm Description
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
Outcomes
Primary Outcome Measures
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers
Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Response to CTRT
All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT
R0 resection rate
All patients will be jointly evaluated for surgery 6 weeks post chemoradiation
Locoregional control
Overall survival
At the median follow up of 3 years the 5 year overall survival rate would be assesed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118897
Brief Title
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Official Title
Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
To assess the resectability rate with microscopic negative margin (R0).
To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
To study the locoregional control in the patients undergoing R0 resection
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms Malignant, Malignant Neoplasm of Gall Bladder Non-resectable
Keywords
Gall bladder, Pancreatic cancers, Tomotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant chemoradiation
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Tomotherapy
Intervention Description
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 Measure Information:
Title
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers
Description
Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Response to CTRT
Description
All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT
Time Frame
3 months
Title
R0 resection rate
Description
All patients will be jointly evaluated for surgery 6 weeks post chemoradiation
Time Frame
6 weeks
Title
Locoregional control
Time Frame
3 years
Title
Overall survival
Description
At the median follow up of 3 years the 5 year overall survival rate would be assesed
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Biopsy proven adenocarcinoma
KPS >= 70
Age >18 years
Medically fit for chemotherapy
Normal hematological, renal and hepatic function (Serum Bilirubin<3mg/dl)
No prior history of treatment with radiation or chemotherapy.
Patient willing and reliable for follow-up.
Exclusion criteria
Any other malignancy in any site.
Expected survival < 3months.
Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)
Malignant ascitis.
Distant metastases by clinical examination or by imaging/whole bodyPET scan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reena Engineer, MD
Organizational Affiliation
Tata Memorial Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
12. IPD Sharing Statement
Learn more about this trial
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
We'll reach out to this number within 24 hrs