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

NCT ID: NCT01304160

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-07-31

Brief 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.

Conditions

Pancreatic Cancer; Unresectable Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

strereotactic radiotherapy, gemcitabine

stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine

Group Type: EXPERIMENTAL

stereotactic body radiotherapy

Intervention Type: RADIATION

30Gray in 5 fractions

Interventions

stereotactic body radiotherapy

30Gray in 5 fractions

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Pierre Campeau, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CE 09.153

Identifier Type: -

Identifier Source: org_study_id