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

Trial ID or NCT#

NCT00238602

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1.Lung tumor \>= 5.0 cm.
  2. 2.Age \> 18 years,
  3. 3.Histologic confirmation of malignancy (primary lung or metastatic tumor)
  4. 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. 5.Performance status of 0-2 by Eastern Clinical Oncology Group criteria
Exclusion Criteria:
  1. 1. No chemotherapy within 2 weeks of radiation treatment.
  2. 2. Refusal to sign informed consent.
  3. 3. Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.

Investigator(s)

Billy W Loo, Jr, MD PhD FASTRO FACR
Billy W Loo, Jr, MD PhD FASTRO FACR
Radiation oncologist, Thoracic specialist
Professor of Radiation Oncology (Radiation Therapy)
Quynh-Thu Le, MD
Quynh-Thu Le, MD
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor

Contact us to find out if this trial is right for you.

Contact

Lisa Zhou
6507364112