Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

Phase 1

Completed

• Conditions: Pancreatic Neoplasms Malignant; Malignant Neoplasm of Gall Bladder Non-resectable
• Interventions: Radiation: Tomotherapy

• Registration Number: NCT01118897
• Lead Sponsor: Tata Memorial Hospital

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

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.

Study Timeline

• Study Start: 2008-12
• Status Verified: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemoradiation	Tomotherapy	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

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers	3 Years	Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, Maharashtra, India