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

This study has been completed.
Sponsor:
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 3, 2016
Last verified: August 2012
  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 ]

Enrollment: 10
Study Start Date: September 2010
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304160

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada, H2L 4M1
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

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 3, 2016
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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016