Back to resultsEvaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility 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.
Sites / Locations
- Stanford University School of Medicine
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00238602
Brief Title
Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer
Official Title
Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Stereotactic radiosurgery
Primary Outcome Measure Information:
Title
Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors
Title
Efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Billy W. Loo Jr. M.D. Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Cancer
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