Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00750269
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2008-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Study Overview
Official Title:
Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients
Status:
COMPLETED
Status Verified Date:
2022-05
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 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 non-small cell lung cancer.
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 non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I)
* To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)
Secondary
* To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.
* To estimate the rates of late adverse events (i.e., occurs \> 1 year after the start of SBRT) in these patients.
* To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks \[total of 5 fractions (FX)\] in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 2 years, then annually.
Primary
* To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I)
* To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)
Secondary
* To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.
* To estimate the rates of late adverse events (i.e., occurs \> 1 year after the start of SBRT) in these patients.
* To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks \[total of 5 fractions (FX)\] in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 2 years, then annually.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: