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

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ClinicalTrials.gov Identifier: NCT00238602
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Procedure: Stereotactic radiosurgery Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2000
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors
  2. Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00238602     History of Changes
Other Study ID Numbers: LUN0008
78730
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

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