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

Phase 1

Completed

• Conditions: Pancreatic Cancer; Unresectable Pancreatic Cancer
• Interventions: Radiation: stereotactic body radiotherapy

• Registration Number: NCT01304160
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2012-08
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
strereotactic radiotherapy, gemcitabine	stereotactic body radiotherapy	stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	one year	Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 monthly	Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire
overall survival	one and two year
Local control	3 monthly	Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada