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

Phase 1
Completed
Conditions
Lung Cancer
Registration Number
NCT00238602
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

Stanford University School of Medicine

🇺🇸

Stanford, California, United States

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