Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer (STARS)
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|ClinicalTrials.gov Identifier: NCT00840749|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 10, 2009
Results First Posted : July 14, 2020
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Radiation: CyberKnife Stereotactic Radiotherapy Procedure: Surgery||Not Applicable|
Primary Goal: To compare overall survival at 3 years.
- To compare disease specific survival at 3 years.
- To compare 3 year progression free survival at the treated primary tumor site
- To compare grade 3 and above acute and/or chronic toxicities.
- To evaluate predictive value of pre and post treatment PET scan in clinical outcome.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|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||
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)
- Overall Survival [ Time Frame: 3 years ]
The study power was calculated for sample size of 420 patients, enrolled over 7 years. The actual enrollment was 36 patients over 4 years. The study was therefore terminated due to lack of enrollment. The sample size does not allow to analysis of the primary outcome.
While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840749
|Principal Investigator:||Jack Roth, M.D.||M.D. Anderson Cancer Center|