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Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00238602
First received: October 11, 2005
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

This study has two primary objectives. The first objective is to determine the maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. Once the MTD is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.


Condition Intervention Phase
Lung Cancer
 Procedure: Stereotactic radiosurgery
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses [ Time Frame: unknown ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: March 2000
Study Completion Date: June 2012
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Stereotactic radiosurgery
    unknown
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1.Lung tumor >= 5.0 cm.

2.Age > 18 years,

3.Histologic confirmation of malignancy (primary lung or metastatic tumor)

4.Deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings.

5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria

Exclusion Criteria:1. No chemotherapy within 2 weeks of radiation treatment.

2. Refusal to sign informed consent.

3. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238602

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00238602     History of Changes
Other Study ID Numbers: LUN0008, 78730, LUN0008
Study First Received: October 11, 2005
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013