Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003855
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
1999-11-01
Brief Title:
Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
Status:
COMPLETED
Status Verified Date:
2020-04
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 Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast
PURPOSE Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer
PURPOSE Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer
Detailed Description:
OBJECTIVES
Primary objectives
Long term To assess whether overall survival for patients randomized to Arm 2 no immediate ALND is essentially equivalent to or better than than that for patients assigned to Arm 1 completion ALND
Short term To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone
OUTLINE This is a randomized study After segmental mastectomy and sentinel lymph node dissection patients are stratified according to age 50 and under vs over 50 estrogen receptor status positive vs negative and tumor size no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm Patients are randomized to one of two treatment arms
Primary objectives
Long term To assess whether overall survival for patients randomized to Arm 2 no immediate ALND is essentially equivalent to or better than than that for patients assigned to Arm 1 completion ALND
Short term To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone
OUTLINE This is a randomized study After segmental mastectomy and sentinel lymph node dissection patients are stratified according to age 50 and under vs over 50 estrogen receptor status positive vs negative and tumor size no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm Patients are randomized to one of two treatment arms
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 |
|---|---|---|---|
| CDR0000067018 | REGISTRY | NCI Physician Data Query | None |
| GUMC-00153 | None | None | None |