Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age
5 other identifiers
interventional
588
5 countries
187
Brief Summary
This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
Longer than P75 for phase_3
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedStudy Start
First participant enrolled
February 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2014
CompletedResults Posted
Study results publicly available
October 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 28, 2022
June 1, 2021
7.6 years
June 28, 2006
April 25, 2016
April 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Probability for Event Free Survival.
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
5 years
Secondary Outcomes (11)
Toxicity Rate
13 weeks
Complete or Partial Response Rate
13 weeks
Percent Tumor Necrosis
13 weeks
Event Free Survival Probability Disease Extent
5 years
Event Free Survival Probability Histologic Grade
5 years
- +6 more secondary outcomes
Study Arms (4)
Arm A: No adjuvant treatment
EXPERIMENTALPatients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).
Arm B: Low risk; adjuvant radiotherapy
EXPERIMENTALPatients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy
EXPERIMENTALHigh risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy
EXPERIMENTALHigh risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
Interventions
Given IV
Patients undergo observation
Patients undergo surgery
Patients undergo radiotherapy
Given IV
Eligibility Criteria
You may qualify if:
- Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
- Metastatic or non metastatic disease
- Meets 1 of the following criteria:
- Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:
- Adipocytic tumor, including liposarcoma of any of the following histology subtypes:
- Dedifferentiated
- Myxoid
- Round cell
- Pleomorphic type
- Mixed-type
- Not otherwise specified (NOS)
- Fibroblastic/myofibroblastic tumors, including any of the following:
- Solitary fibrous tumor
- Hemangiopericytoma
- Low-grade myofibroblastic sarcoma
- +72 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (187)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Children's Oncology Group
Arcadia, California, 91006-3776, United States
Southern California Permanente Medical Group
Downey, California, 90242, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Children's Hospital Central California
Madera, California, 93636-8762, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Childrens Hospital of Orange County
Orange, California, 92868-3874, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06520-8032, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Lee Memorial Health System
Fort Myers, Florida, 33901, United States
University of Florida
Gainesville, Florida, 32610, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207-8426, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Florida Hospital
Orlando, Florida, 32803, United States
M D Anderson Cancer Center- Orlando
Orlando, Florida, 32806, United States
Nemours Childrens Clinic - Orlando
Orlando, Florida, 32806, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Memorial Health University Medical Center
Savannah, Georgia, 31403, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
University of Illinois
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61602, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48202, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, 49008, United States
Michigan State University - Breslin Cancer Center
Lansing, Michigan, 48910, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
The Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Albany Medical Center
Albany, New York, 12208, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
New York University Langone Medical Center
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
New York Medical College
Valhalla, New York, 10595, United States
Mission Hospitals Inc
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Mercy Children's Hospital
Toledo, Ohio, 43608, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Tech University Health Science Center-Amarillo
Amarillo, Texas, 79106, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
University of Vermont
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, Australia
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8S 4L8, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Starship Children's Hospital
Grafton, Auckland, 1145, New Zealand
San Jorge Children's Hospital
Santurce, 00912, Puerto Rico
Related Publications (7)
Crane JN, Xue W, Qumseya A, Barkauskas DA, Chau K, Tan SY, Hiniker S, Dasgupta R, Venkatramani R, Spunt SL, Weiss AR, Laetsch TW. Malignant peripheral nerve sheath tumors: a report from children's oncology group study ARST0332. J Natl Cancer Inst. 2025 Dec 12:djaf359. doi: 10.1093/jnci/djaf359. Online ahead of print.
PMID: 41386267DERIVEDAlvarez E, He J, Spunt SL, Hayes-Jordan A, Kao SC, Parham DM, Million L, Weiss AR, Barkauskas DA. Lymph node metastases in paediatric and young adult patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): Findings from Children's Oncology Group (COG) study ARST0332. Eur J Cancer. 2023 Feb;180:89-98. doi: 10.1016/j.ejca.2022.11.014. Epub 2022 Nov 25.
PMID: 36566574DERIVEDVenkatramani R, Xue W, Randall RL, Wolden S, Anderson J, Lopez-Terrada D, Black J, Kao SC, Shulkin B, Ostrenga A, Pappo A, Spunt SL. Synovial Sarcoma in Children, Adolescents, and Young Adults: A Report From the Children's Oncology Group ARST0332 Study. J Clin Oncol. 2021 Dec 10;39(35):3927-3937. doi: 10.1200/JCO.21.01628. Epub 2021 Oct 8.
PMID: 34623899DERIVEDMillion L, Hayes-Jordan A, Chi YY, Donaldson SS, Wolden S, Morris C, Terezakis S, Laurie F, Morano K, Fitzgerald TJ, Yock TI, Rodeberg DA, Anderson JR, Speights RA, Black JO, Coffin C, McCarville MB, Kao SC, Hawkins DS, Spunt SL, Randall RL. Local Control For High-Grade Nonrhabdomyosarcoma Soft Tissue Sarcoma Assigned to Radiation Therapy on ARST0332: A Report From the Childrens Oncology Group. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):821-830. doi: 10.1016/j.ijrobp.2021.01.051. Epub 2021 Feb 3.
PMID: 33548339DERIVEDSpunt SL, Million L, Chi YY, Anderson J, Tian J, Hibbitts E, Coffin C, McCarville MB, Randall RL, Parham DM, Black JO, Kao SC, Hayes-Jordan A, Wolden S, Laurie F, Speights R, Kawashima E, Skapek SX, Meyer W, Pappo AS, Hawkins DS. A risk-based treatment strategy for non-rhabdomyosarcoma soft-tissue sarcomas in patients younger than 30 years (ARST0332): a Children's Oncology Group prospective study. Lancet Oncol. 2020 Jan;21(1):145-161. doi: 10.1016/S1470-2045(19)30672-2. Epub 2019 Nov 27.
PMID: 31786124DERIVEDSpunt SL, Francotte N, De Salvo GL, Chi YY, Zanetti I, Hayes-Jordan A, Kao SC, Orbach D, Brennan B, Weiss AR, van Noesel MM, Million L, Alaggio R, Parham DM, Kelsey A, Randall RL, McCarville MB, Bisogno G, Hawkins DS, Ferrari A. Clinical features and outcomes of young patients with epithelioid sarcoma: an analysis from the Children's Oncology Group and the European paediatric soft tissue Sarcoma Study Group prospective clinical trials. Eur J Cancer. 2019 May;112:98-106. doi: 10.1016/j.ejca.2019.02.001. Epub 2019 Apr 5.
PMID: 30954717DERIVEDFerrari A, Chi YY, De Salvo GL, Orbach D, Brennan B, Randall RL, McCarville MB, Black JO, Alaggio R, Hawkins DS, Bisogno G, Spunt SL. Surgery alone is sufficient therapy for children and adolescents with low-risk synovial sarcoma: A joint analysis from the European paediatric soft tissue sarcoma Study Group and the Children's Oncology Group. Eur J Cancer. 2017 Jun;78:1-6. doi: 10.1016/j.ejca.2017.03.003. Epub 2017 Apr 7.
PMID: 28391003DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Sheri Spunt, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 29, 2006
Study Start
February 5, 2007
Primary Completion
September 5, 2014
Study Completion
March 31, 2022
Last Updated
April 28, 2022
Results First Posted
October 6, 2017
Record last verified: 2021-06