Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00843726|
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Arm 1 stereotactic body radiation therapy Radiation: Arm II stereotactic body radiation therapy||Phase 2|
- To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.
- To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.
- To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
- Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
After completion of study treatment, patients are followed for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer|
|Actual Study Start Date :||September 12, 2008|
|Actual Primary Completion Date :||May 6, 2020|
|Actual Study Completion Date :||May 6, 2020|
Experimental: Arm I
Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
Radiation: Arm 1 stereotactic body radiation therapy
Patients undergo 1 high-dose fraction
Experimental: Arm II
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
Radiation: Arm II stereotactic body radiation therapy
Patients undergo 3 high-dose fractions
- Incidence of AE Grade 3 or Higher Toxicity [ Time Frame: 1year ]Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
- Overall Survival [ Time Frame: 5 years ]Median overall survival
- Correlation Between Blood and Serum Markers and Survival and Toxicity [ Time Frame: 4 years ]
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): NCT00843726
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Anurag K. Singh, MD||Roswell Park Cancer Institute|