Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Conditions
Pancreatic Cancer - Unresectable Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
pancreatic cancer, stereotactic body radiotherapy, radiation, gemcitabine, locally advanced
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: stereotactic body radiotherapy
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.
Detailed Description
The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.

The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pancreatic Adenocarcinoma, histologically and/or cytologically proven

- Locally advanced pancreatic cancer, surgically non resectable

- No distant metastasis

- Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis

- ECOG performance status : ≤ 2

- Primary tumor visible on CT-scan

- Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)

- White blood cell count > 3000 /uL, Neutrophils > 1500 /uL, Platelets > 100 000/uL, Hemoglobin > 95 mg/L, Total bilirubin < 1,5 normal limit, AST/ALT < 2,5 normal limit, normal creatinin

- ≥ 18 years of age

- Signed informed consent

Exclusion Criteria:

- Prior abdominal radiation therapy

- Connective tissue disease (scleroderma, lupus)

- Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.
Location
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada
Status: Recruiting
Start Date
September 2010
Completion Date
July 2013
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Source
Centre hospitalier de l'Université de Montréal (CHUM)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page