Trial Information
Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximal tolerated dose (MTD) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors
Outcome Time Frame:
unknown
Safety Issue:
Yes
Principal Investigator
Dr. Billy W. Loo Jr. M.D. Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Institutional Review Board
Study ID:
LUN0008
NCT ID:
NCT00238602
Start Date:
March 2000
Completion Date:
June 2012
Related Keywords:
- Lung Cancer
- Lung Neoplasms
Name | Location |
Stanford University School of Medicine |
Stanford, California 94305-5317 |