Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003830
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
1999-11-01
Brief Title:
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Randomized Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-11
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 Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer
Detailed Description:
OBJECTIVES
Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative
Compare the effect of these two regimens on the overall and disease-free survival of these patients
Compare the morbidity associated with these two regimens in these patients
Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology
Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology
Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons
Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients
Objectives of quality of life questionnaire in sentinel node-negative patients
Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens
Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side
Compare the impact of arm edema range of motion and sensory neuropathy on self-assessed measures of daily functioning symptoms and overall quality of life of patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to the surgical treatment plan lumpectomy vs mastectomy age 49 and under vs 50 and over and clinical tumor size no greater than 20 cm vs 21-40 cm vs at least 41 cm Patients are randomized to one of two surgery arms
All patients receive technetium Tc 99m sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium Tc 99m sulfur colloid approximately 05-8 hours before surgery Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector If a hot spot is not identified the blue dye is injected after a saline bolus injection
Arm I Patients undergo sentinel node resection immediately followed by conventional axillary dissection
Arm II Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes
Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection
Patients with cytologically negative sentinel nodes do not undergo axillary dissection
Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection
Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection
Patients with pathologically positive nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection
Patients with evidence of tumor remaining after surgery undergo a total mastectomy
Quality of life is assessed at baseline at weeks 1-3 and then every 6 months for 3 years or until recurrence
Patients are followed at 1 and 3 weeks every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 5400 patients will be accrued for this study within 4 years
Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative
Compare the effect of these two regimens on the overall and disease-free survival of these patients
Compare the morbidity associated with these two regimens in these patients
Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology
Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology
Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons
Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients
Objectives of quality of life questionnaire in sentinel node-negative patients
Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens
Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side
Compare the impact of arm edema range of motion and sensory neuropathy on self-assessed measures of daily functioning symptoms and overall quality of life of patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to the surgical treatment plan lumpectomy vs mastectomy age 49 and under vs 50 and over and clinical tumor size no greater than 20 cm vs 21-40 cm vs at least 41 cm Patients are randomized to one of two surgery arms
All patients receive technetium Tc 99m sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium Tc 99m sulfur colloid approximately 05-8 hours before surgery Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector If a hot spot is not identified the blue dye is injected after a saline bolus injection
Arm I Patients undergo sentinel node resection immediately followed by conventional axillary dissection
Arm II Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes
Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection
Patients with cytologically negative sentinel nodes do not undergo axillary dissection
Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection
Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection
Patients with pathologically positive nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection
Patients with evidence of tumor remaining after surgery undergo a total mastectomy
Quality of life is assessed at baseline at weeks 1-3 and then every 6 months for 3 years or until recurrence
Patients are followed at 1 and 3 weeks every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 5400 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| CDR0000066987 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA012027 |
| U10CA012027 | NIH | None | None |