- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304160
Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal (CHUM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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.
Study Plan
How is the study designed?
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 |
---|---|
Experimental: strereotactic radiotherapy, gemcitabine
stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine
|
30Gray in 5 fractions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: one year
|
Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 3 monthly
|
Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire
|
3 monthly
|
Local control
Time Frame: 3 monthly
|
Local 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
Time Frame: one and two year
|
one and two year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marie-Pierre Campeau, MD, Centre Hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE 09.153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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