Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471835
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2007-05-08
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Study of Hypofractionated Stereotactic Body Radiotherapy for Stage III Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography
Status:
WITHDRAWN
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 III 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
PURPOSE This phase III 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
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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 PETCT 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-PETCT 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
Primary
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
Secondary
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 PETCT 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-PETCT 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU-IRB00000578 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000543743 | REGISTRY | None | None |