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

This study is ongoing, but not recruiting participants.

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00238602

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 I Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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

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
Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses

Estimated Enrollment:	60
Study Start Date:	March 2000

Eligibility

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

Criteria

Inclusion Criteria:1.Lung tumor d 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

Study ID Numbers:	LUN0008, 78730, LUN0008, NCT00238602
Study First Received:	October 11, 2005
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00238602
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009