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: June 7, 2012
Last verified: June 2012
  Purpose

This study will assess the efficacy of treating locally advanced pancreatic cancer using a linear accelerator designed for image-guided radiotherapy


Condition Intervention Phase
Pancreatic Cancer
Drug: gemcitabine chemotherapy
Procedure: fiducial seed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Body Radiotherapy (SBRT) for Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Overall survival and quality of life [ Time Frame: unknown ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: December 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gemcitabine chemotherapy
    standard treatment
    Procedure: fiducial seed
    The method of placement will be left to the discretion of the attending physician.
  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
  • ECOG status of 0, 1, or 2
  • No chemotherapy two weeks prior or two weeks following radiosurgery

Exclusion Criteria:- Patients without pancreatic cancer

  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, 95655, PANC0005
Study First Received: July 5, 2006
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

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 July 22, 2014