Spots Global Cancer Trial Database for Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
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Trial Identification
Brief Title: Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
Official Title: ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping
Study ID: NCT03927027
Study Description
Brief Summary: This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping \[ARM\]) versus Group II (ARM). SECONDARY OBJECTIVES: I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics. III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM. EXPLORATORY OBJECTIVES: I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND). GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. After completion of study, patients are followed up for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Saint John's Cancer Institute, Santa Monica, California, United States
Shaw Cancer Center, Edwards, Colorado, United States
Beebe South Coastal Health Campus, Frankford, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall, Miami, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States
Piedmont Fayette Hospital, Fayetteville, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Goshen Center for Cancer Care, Goshen, Indiana, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
McLaren Cancer Institute-Bay City, Bay City, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Henry Ford Wyandotte Hospital, Wyandotte, Michigan, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township, Sewell, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States
Cancer Institute at Saint Francis Hospital, East Hills, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Pluta Cancer Center, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
Good Samaritan Hospital Medical Center, West Islip, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Cleveland Clinic Akron General, Akron, Ohio, United States
UHHS-Chagrin Highlands Medical Center, Beachwood, Ohio, United States
Geauga Hospital, Chardon, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Mount Carmel East Hospital, Columbus, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights, Ohio, United States
Mount Carmel New Albany Surgical Hospital, New Albany, Ohio, United States
University Hospitals Parma Medical Center, Parma, Ohio, United States
University Hospitals Portage Medical Center, Ravenna, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky, Ohio, United States
University Hospitals Sharon Health Center, Wadsworth, Ohio, United States
University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center, Westlake, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Geisinger South Wilkes-Barre, Wilkes-Barre, Pennsylvania, United States
Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
UTMB Health Angleton Danbury Campus, Angleton, Texas, United States
MD Anderson in The Woodlands, Conroe, Texas, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson West Houston, Houston, Texas, United States
MD Anderson League City, League City, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
VCU Massey Cancer Center at Stony Point, Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus, Brookfield, Wisconsin, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road, Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Contact Details
Name: V. Suzanne Klimberg, MD, PhD
Affiliation: University of Texas
Role: STUDY_CHAIR
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