Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107172
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2005-04-05
Brief Title:
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer NSCLC 3cm or Smaller
Status:
COMPLETED
Status Verified Date:
2019-10
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:
This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer Surgery may be an effective treatment for non-small cell lung cancer Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To ascertain whether patients treated by sublobar resection SR brachytherhapy BX have longer time to local recurrence as compared to the patients treated by SR local recurrence includes recurrence within the same lobe or hilum N1 nodes or progression at the staple line after treatment effects such as scarring have subsided
SECONDARY OBJECTIVES
I To compare procedure specific morbidity and mortality between study arms II To compare overall survival and failure-free survival between study arms III To assess freedom from regional or distant recurrence IV To assess the effect of histological or cytologic positive resection margins on time to local recurrence
V To determine the effect of brachytherapy on quality of life QoL VI To determine the effect of brachytherapy on pulmonary function
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy
ARM II Patients undergo surgery as in arm I Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin
After completion of study treatment patients are followed at 3 6 12 18 24 30 and 36 months and then yearly for 2 years
I To ascertain whether patients treated by sublobar resection SR brachytherhapy BX have longer time to local recurrence as compared to the patients treated by SR local recurrence includes recurrence within the same lobe or hilum N1 nodes or progression at the staple line after treatment effects such as scarring have subsided
SECONDARY OBJECTIVES
I To compare procedure specific morbidity and mortality between study arms II To compare overall survival and failure-free survival between study arms III To assess freedom from regional or distant recurrence IV To assess the effect of histological or cytologic positive resection margins on time to local recurrence
V To determine the effect of brachytherapy on quality of life QoL VI To determine the effect of brachytherapy on pulmonary function
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy
ARM II Patients undergo surgery as in arm I Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin
After completion of study treatment patients are followed at 3 6 12 18 24 30 and 36 months and then yearly for 2 years
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 |
|---|---|---|---|
| ACOSOG-Z4032 | None | None | None |
| CDR0000422346 | REGISTRY | NCI Physician Data Query | None |