NCT00840749

Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer

International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Accuray Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

Detailed description

Objectives: Primary Goal: To compare overall survival at 3 years. Secondary goals: 1. To compare disease specific survival at 3 years. 2. To compare 3 year progression free survival at the treated primary tumor site 3. To compare grade 3 and above acute and/or chronic toxicities. 4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	CyberKnife Stereotactic Radiotherapy	Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
PROCEDURE	Surgery	Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-02-10
• Last updated: 2020-07-14
• Results posted: 2020-07-14

Locations

19 sites across 4 countries: United States, China, France, Taiwan