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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was  Recruiting
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 6, 2012
Last verified: August 2012

February 21, 2011
August 6, 2012
September 2010
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01304160 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Unresectable Pancreatic Cancer
Radiation: stereotactic body radiotherapy
30Gray in 5 fractions
Experimental: strereotactic radiotherapy, gemcitabine
stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine
Intervention: Radiation: stereotactic body radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marie-Pierre campeau, MD 514-890-8254 marie-pierre.campeau.chum@ssss.gouv.qc.ca
Canada
 
NCT01304160
CE 09.153
Yes
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Principal Investigator: Marie-Pierre Campeau, MD Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP