Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
This study is currently recruiting participants.
Verified August 2012 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01304160
First received: February 21, 2011
Last updated: August 6, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Unresectable Pancreatic Cancer |
Radiation: stereotactic body radiotherapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):
Primary Outcome Measures:
- Number of participants with adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0
Secondary Outcome Measures:
- Quality of life [ Time Frame: 3 monthly ] [ Designated as safety issue: No ]Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire
- Local control [ Time Frame: 3 monthly ] [ Designated as safety issue: No ]Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.
- overall survival [ Time Frame: one and two year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: strereotactic radiotherapy, gemcitabine
stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine
|
Radiation: stereotactic body radiotherapy
30Gray in 5 fractions
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304160
Contacts
| Contact: Marie-Pierre campeau, MD | 514-890-8254 | marie-pierre.campeau.chum@ssss.gouv.qc.ca |
Locations
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Recruiting |
| Montréal, Quebec, Canada, H2L 4M1 | |
| Sub-Investigator: Sophie Lavertu, MD | |
| Sub-Investigator: David Donath, MD | |
| Sub-Investigator: Bernard Fortin, MD | |
| Sub-Investigator: Richard Létourneau, MD | |
| Sub-Investigator: Jean-Pierre Ayoub, MD | |
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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) |
More Information
No publications provided
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01304160 History of Changes |
| Other Study ID Numbers: | CE 09.153 |
| Study First Received: | February 21, 2011 |
| Last Updated: | August 6, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
pancreatic cancer stereotactic body radiotherapy radiation gemcitabine locally advanced |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013