Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Albert Koong, Stanford University
ClinicalTrials.gov Identifier:
NCT00350142
First received: July 5, 2006
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine


Condition Intervention Phase
Pancreatic Cancer
Radiation: Stereotactic Body Radiotherapy
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Rate of Local Control [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

    The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.

    Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.



Secondary Outcome Measures:
  • Median Overall Survival Time [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.


Enrollment: 20
Study Start Date: April 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radiotherapy
single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine
Radiation: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator
Other Name: single fraction 25 Gy dose Stereotactic Body Radiotherapy
Drug: Gemcitabine
Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Pancreatic tumors not to exceed 10 cm in greatest axial dimension

  • Histologically confirmed malignancies of the pancreas
  • Unresectable by CT criteria or exploratory laparotomy or laparoscopy
  • Patients with metastatic disease may be treated if they are symptomatic from the primary tumor
  • Performance status of 0, 1, or 2
  • No chemotherapy two weeks prior or two weeks following radiosurgery

Exclusion Criteria:

  • patients who have had prior radiotherapy to upper abdomen
  • patients receiving any prior pancreatic cancer therapy
  • children, pregnant, and breastfeeding women, and lab personnel are excluded
  • uncontrolled intercurrent illnesses
  • any concurrent malignancy
  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: NCT00350142

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Albert Koong
Investigators
Principal Investigator: Albert Koong Stanford University
  More Information

No publications provided

Responsible Party: Albert Koong, Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT00350142     History of Changes
Other Study ID Numbers: PANC0005, PANC0005
Study First Received: July 5, 2006
Results First Received: December 6, 2013
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Stereotactic Body Radiotherapy (SBRT)
pancreas cancer
locally advanced
local control
Gemcitabine

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 September 16, 2014