Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms Malignant; Malignant Neoplasm of Gall Bladder Non-resectable
• Intervention / Treatment: Radiation: Tomotherapy

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
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to CTRT	All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT	3 months
R0 resection rate	All patients will be jointly evaluated for surgery 6 weeks post chemoradiation	6 weeks
Locoregional control		3 years
Overall survival	At the median follow up of 3 years the 5 year overall survival rate would be assesed	3 years

Collaborators and Investigators

• Sponsor: Tata Memorial Hospital
• Investigators: Principal Investigator: Reena Engineer, MD, Tata Memorial Centre

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 6, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Tomotherapy; Gall bladder; Pancreatic cancers
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Biliary Tract Neoplasms; Neoplasms; Pancreatic Neoplasms; Gallbladder Neoplasms
• Other Study ID Numbers: IRB 599