Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00471835|
Recruitment Status : Withdrawn
First Posted : May 10, 2007
Last Update Posted : January 19, 2017
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: computed tomography Procedure: positron emission tomography Radiation: stereotactic body radiation therapy||Phase 1 Phase 2|
- Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II non-small cell lung cancer. (Phase I)
- Determine local control and time to local progression in patients treated with this regimen. (Phase II)
- Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18 (FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control and time to progression in these patients.
- Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to predict long-term local control and time to progression in these patients.
- Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT, to predict local control and time to progression in these patients.
- Determine the utility of PET/CT scan data in guiding treatment planning.
- Determine if treatment with radiotherapy involving high biological doses with limited treatment volume using these SBRT techniques achieves acceptable treatment-related toxicity.
OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.
- Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3 times within a 2-week time frame.
Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16 weeks after completion of SBRT.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography|
|Study Start Date :||January 2007|
- Maximum tolerated dose (Phase I)
- Time to progression and local control at 1 and 2 years (Phase II)
- Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms
- Patterns of failure and overall survival at 2 years
- Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 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): NCT00471835
|Study Chair:||Volker W. Stieber, MD||Wake Forest University Health Sciences|