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

ClinicalTrials.gov ID NCT01304160
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by Centre hospitalier de l'Université de Montréal (CHUM) (Responsible Party)
Last Update Posted 2016-08-05
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Study Overview

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.

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Official Title
Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Conditions
Pancreatic Cancer
Unresectable Pancreatic Cancer
Intervention / Treatment
  • Radiation: stereotactic body radiotherapy
  • Radiation: stereotactic body radiotherapy
Other Study ID Numbers
  • CE 09.153
Study Start
2010-09
Primary Completion (Actual)
2016-07
Study Completion (Actual)
2016-07
Enrollment (Actual)
10
Study Type
Interventional
Phase
Phase 1Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: strereotactic radiotherapy, gemcitabine
stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine
Intervention/Treatment Radiation: stereotactic body radiotherapy
  • 30Gray in 5 fractions

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Number of participants with adverse eventsAcute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0one year
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Quality of lifeQuality of life will be evaluated with the EORTC QLQ-C30 questionnaire3 monthly
Local controlLocal control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.3 monthly
overall survival one and two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
  • Principal Investigator:Marie-Pierre Campeau, MD,Centre hospitalier de l'Université de Montréal (CHUM)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2011-02-21
First Submitted that Met QC Criteria
2011-02-24
First Posted (Estimated)
2011-02-25
Study Record Updates
Last Update Submitted that met QC Criteria
2016-08-03
Last Update Posted (Estimated)
2016-08-05
Last Verified
2012-08

More Information

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Keywords Provided by Centre hospitalier de l'Université de Montréal (CHUM)
Additional Relevant MeSH Terms