Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087438
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2004-07-08
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Trial of Stereotactic Body Radiation Therapy SBRT in the Treatment of Patients With Medically Inoperable Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-12
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 Radiation therapy uses high-energy x-rays to damage tumor cells Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue
PURPOSE This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer
PURPOSE This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether treatment with stereotactic body radiotherapy results in acceptable local control ie 80 in patients with medically inoperable stage I or II non-small cell lung cancer
Secondary
Determine treatment-related toxicity in patients treated with this therapy
Determine disease-free survival overall survival and patterns of failure in patients treated with this therapy
OUTLINE This is a multicenter study
Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity
Patients are followed up at 6 and 12 weeks every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study within 26 months
Primary
Determine whether treatment with stereotactic body radiotherapy results in acceptable local control ie 80 in patients with medically inoperable stage I or II non-small cell lung cancer
Secondary
Determine treatment-related toxicity in patients treated with this therapy
Determine disease-free survival overall survival and patterns of failure in patients treated with this therapy
OUTLINE This is a multicenter study
Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity
Patients are followed up at 6 and 12 weeks every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study within 26 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000371578 | None | None | None |