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Evaluation of the Cyberknife Precision Radiation Delivery System for Unresectable Malignant Lung Tumors - A Phase I/II Study


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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