Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Procedure: conventional surgeryProcedure: Sentinel node resection followed by node examination
- Registration Number
- NCT00003830
- Lead Sponsor
- NSABP Foundation Inc
- 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.
- 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 2.0 cm vs 2.1-4.0 cm vs at least 4.1 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 0.5-8 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 5,400 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 5611
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I: Conventional axillary dissection conventional surgery Sentinel node resection immediately followed by axillary dissection Arm II: Sentinel node resection followed by node examination Sentinel node resection followed by node examination Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
- Primary Outcome Measures
Name Time Method Overall Survival 8 years Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit Before and after surgery (within 30 days of randomization) Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.
Morbidity - Number of Participants With Residual Arm Numbness before and after surgery (within 30 days of randomization) Morbidity as measured by residual arm numbness
Morbidity - Number of Participants With Residual Arm Tingling before and after surgery (within 30 days of randomization) Morbidity as measured by residual arm tingling
Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. 8 years Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
Morbidity - Number of Participants With Residual Arm Volume Difference before and after surgery (within 30 days of randomization) Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery
- Secondary Outcome Measures
Name Time Method Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence From the time of randomization until 5 years Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified. At time of surgery (within 30 days of randomization) Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases. At time of surgery (within 30 days of randomization) Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
Trial Locations
- Locations (78)
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Camcare Health
🇺🇸Charleston, West Virginia, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
University of Miami Sylvester Cancer Center
🇺🇸Miami, Florida, United States
MBCCOP-Cook County Hospital
🇺🇸Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Methodist Cancer Center at Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Northern Indiana CR Consortium
🇺🇸S. Bend, Indiana, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Michigan State University
🇺🇸E. Lansing, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oaks, Michigan, United States
Providence Cancer Institute at Providence Hospital
🇺🇸Southfield, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
🇺🇸Albany, New York, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Virginia Oncology Associates - Newport News
🇺🇸Newport News, Virginia, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital Center
🇨🇦Montreal, Quebec, Canada
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Jewish Hospital of Cincinnati, Incorporated
🇺🇸Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Allegheny General Hospital
🇺🇸Pittsburg, Pennsylvania, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Sutter Breast Cancer Group
🇺🇸Sacramento, California, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Royal Victoria Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States