Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00960999|
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : November 4, 2014
Last Update Posted : December 18, 2018
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which regimen of stereotactic body 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 non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Single-fraction stereotactic body radiation therapy (SBRT) Radiation: Multiple-fraction stereotactic body radiation therapy (SBRT)||Phase 2|
- To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment with single fraction vs multiple fraction stereotactic body radiotherapy in medically inoperable patients with stage I peripheral non-small cell lung cancer.
- To estimate the 1-year primary tumor control rate in these patients.
- To estimate the 1-year overall survival and disease-free survival rate of these patients.
- To assess FDG-PET (fluorodeoxyglucose) standardized uptake value changes as a measure of treatment response and outcomes.
- To determine pulmonary function changes by treatment arm and response.
- To determine the association between biomarkers and primary tumor control and/or ≥ grade 2 radiation pneumonitis.
OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment arms.
- Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT) treatment to the target lesion.
- Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for 4 days.
Blood and tumor tissue samples may be collected for further analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||May 14, 2018|
Experimental: Single-fraction SBRT (34 Gy)
Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
Radiation: Single-fraction stereotactic body radiation therapy (SBRT)
34 Gy in 1 fraction to the prescription line at the edge of the planning target volume (PTV). The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and < 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least < 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be < 10%.
Experimental: Multiple-fraction SBRT (48 Gy)
Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
Radiation: Multiple-fraction stereotactic body radiation therapy (SBRT)
48 Gy in four 12 Gy fractions to the prescription line at the edge of the planning target volume (PTV). Treatments are given on 4 consecutive calendar days, but at least 18 hours apart. The maximum dose must exist within the PTV, and the prescription isodose surface must be ≥ 60% and < 90% of the maximum dose. 99% of the PTV must receive a minimum of 90% of the prescription dose. The maximum dose to any point ≥ 2 cm away from the PTV in any direction must be at least < 50% of the prescription dose. The percent of the lungs (excluding PTV) receiving 20 Gy or more must be < 10%.
- Counts of ≥ Grade 3 Adverse Events (AE) Graded by CTCAE v4 (Common Terminology Criteria for Adverse Events) That Are Definitely, Probably, or Possibly Related to Treatment (DPPRT) [ Time Frame: From start of treatment to 1 year ]Number of patients with ≥ grade 3 AE occurring within 1 year of treatment (TRT) start and reported as DPPRT among this subset of CTCAE v4: pericardial effusion, pericarditis, restrictive cardiomyopathy, dysphagia, esophagitis, esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage, rib fracture, brachial plexopathy, recurrent laryngeal nerve palsy, myelitis, atelectasis, bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, bronchial/pulmonary/bronchopleural/tracheal fistula, hypoxia, bronchial/tracheal obstruction, pleural effusion, pneumonitis, pulmonary fibrosis, skin ulceration (thorax only), FEV1 (Forced Expiratory Volume) or FVC (forced vital capacity) decline, or grade 5 related to TRT. Each arm is considered independently. For each arm, >=5 of 38 analyzable subjects experiencing a grade ≥ 3 AE during the 1st year following TRT start would determine the respective TRT excessively toxic. For each arm this design provides 88% power with a 0.10 type I error rate.
- 1-year Primary Tumor Control Rate [ Time Frame: From start of treatment to 1 year ]
- 1-year Overall Survival and Disease-free Survival Rate [ Time Frame: From start of treatment to 1 year ]
- Distribution of FDG-PET (Fluorodeoxyglucose) Standardized Uptake Value Changes as a Potential Measure of Treatment Response and Outcomes [ Time Frame: From start of treatment to date of failure (local, regional or distant), death or last follow-up. ]
- Distribution of Pulmonary Function Changes by Treatment Arm and Response [ Time Frame: From start of treatment to end of follow-up. ]
- Association Between Biomarkers, Primary Tumor Control Rate, and ≥ Grade 2 Radiation Pneumonitis [ Time Frame: From start of treatment to 1 year ]
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): NCT00960999
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|Study Chair:||Gregory Videtic, MD||The Cleveland Clinic|