Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Unresectable Pancreatic Cancer

Pancreatic Cancer

Treatments

Radiation: stereotactic body radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01304160

CE 09.153

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.