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| Sponsor: | Accuray Incorporated |
|---|---|
| Collaborator: |
M.D. Anderson Cancer Center |
| Information provided by (Responsible Party): | Accuray Incorporated |
| ClinicalTrials.gov Identifier: | NCT00840749 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Radiation: CyberKnife Stereotactic Radiotherapy Procedure: Surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer |
| Estimated Enrollment: | 420 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CyberKnife Stereotactic Radiotherapy |
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
Other Name: CyberKnife SBRT, CyberKnife SRT, CyberKnife SRS
|
| Active Comparator: Surgery |
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
Other Name: Open thoracotomy, video assisted thoracotomy (VATS)
|
Objectives:
Primary Goal: To compare overall survival at 3 years.
Secondary goals:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASCL state IA or IB based on only one of the following combinations of TNM staging:
T1, N0, M0 or T2 (<=4 cm), N0, M0
Exclusion Criteria:
Contacts and Locations| Contact: Jan Jenkins | (408) 338-9372 | jjenkins@accuray.com |
| Contact: Omar Dawood, MD, MPH | 408-789-4457 | odawood@accuray.com |
Show 21 Study Locations| Principal Investigator: | Jack Roth, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Accuray Incorporated |
| ClinicalTrials.gov Identifier: | NCT00840749 History of Changes |
| Other Study ID Numbers: | STARS |
| Study First Received: | February 7, 2009 |
| Last Updated: | February 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
STARS Early Stage Non Small Cell Lung Cancer NSCLC |
CyberKnife Surgery Accuray |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |