NCT00852644

Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.

Detailed description

OBJECTIVES: * To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer. * To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment. OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks. Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment. After completion of study treatment, patients are followed periodically for up to 4 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	computed tomography	Standard CT scans
RADIATION	fludeoxyglucose F 18	standard doses with CT scans
RADIATION	hypofractionated radiation therapy	4 doses over 2 weeks
RADIATION	stereotactic radiosurgery	CyberKnife radiosurgery

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-06-01
• Completion: 2016-08-01
• First posted: 2009-02-27
• Last updated: 2018-05-11
• Results posted: 2018-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study