🔎 Trials Near Me

Home › NCT06513962

Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

RecruitingPhase 3

Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer

Who can join

Up to age 39 · Women

Full eligibility criteria
Inclusion Criteria:

* \< 40 years of age at the time of enrollment
* Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
* Newly diagnosed with first cancer, exclusive of breast cancer.

  * Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
* Expected cumulative cyclophosphamide equivalent dose (CED):

  * For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
  * For patients ≥ 20 years of age and \< 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
  * For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.

Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.

* The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria:

* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
* Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
* Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
* Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
* Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
* Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
* Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
* Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
* Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

About the study

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

What is being tested

Sponsor: Children's Oncology Group · Participants: 60 · Started: Feb 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06513962

Locations in the U.S.

AlabamaChildren's Hospital of Alabama, Birmingham
University of Alabama at Birmingham Cancer Center, Birmingham
USA Health Strada Patient Care Center, Mobile
ArizonaPhoenix Childrens Hospital, Phoenix
Banner University Medical Center - Tucson, Tucson
ArkansasMercy Hospital Fort Smith, Fort Smith
Arkansas Children's Hospital, Little Rock
CARTI Cancer Center, Little Rock
CaliforniaCity of Hope Comprehensive Cancer Center, Duarte
UC San Diego Moores Cancer Center, La Jolla
Loma Linda University Medical Center, Loma Linda
Mattel Children's Hospital UCLA, Los Angeles
Kaiser Permanente-Oakland, Oakland
Children's Hospital of Orange County, Orange
Sutter Medical Center Sacramento, Sacramento
Rady Children's Hospital - San Diego, San Diego
ColoradoChildren's Hospital Colorado, Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver
ConnecticutConnecticut Children's Medical Center, Hartford
DelawareBeebe Medical Center, Lewes
Beebe South Coastal Health Campus, Millville
Christiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
Alfred I duPont Hospital for Children, Wilmington
Christiana Care Health System-Wilmington Hospital, Wilmington
District of ColumbiaChildren's National Medical Center, Washington D.C.
FloridaGolisano Children's Hospital of Southwest Florida, Fort Myers
UF Health Cancer Institute - Gainesville, Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood
Nemours Children's Clinic-Jacksonville, Jacksonville
Miami Cancer Institute, Miami
Nicklaus Children's Hospital, Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
AdventHealth Orlando, Orlando
Nemours Children's Hospital, Orlando
Nemours Children's Clinic - Pensacola, Pensacola
Tampa General Hospital, Tampa
Saint Mary's Medical Center, West Palm Beach
GeorgiaChildren's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta
HawaiiKapiolani Medical Center for Women and Children, Honolulu
IllinoisOSF Saint Anthony's Health Center, Alton
Lurie Children's Hospital-Chicago, Chicago
Northwestern University, Chicago
University of Illinois, Chicago
Northwestern Medicine Cancer Center Kishwaukee, DeKalb
Northwestern Medicine Cancer Center Delnor, Geneva
Northwestern Medicine Glenview Outpatient Center, Glenview
Northwestern Medicine Grayslake Outpatient Center, Grayslake
Northwestern Medicine Lake Forest Hospital, Lake Forest
SSM Health Good Samaritan, Mount Vernon
Carle BroMenn Medical Center, Normal
Carle Cancer Institute Normal, Normal
Advocate Children's Hospital-Oak Lawn, Oak Lawn
Northwestern Medicine Orland Park, Orland Park
Advocate Children's Hospital-Park Ridge, Park Ridge
Memorial Hospital East, Shiloh
Saint John's Hospital, Springfield
Southern Illinois University School of Medicine, Springfield
Northwestern Medicine Cancer Center Warrenville, Warrenville
IndianaIndiana University/Melvin and Bren Simon Cancer Center, Indianapolis
Riley Hospital for Children, Indianapolis
IowaUI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny
Saint Anthony Regional Hospital, Carroll
Mercy Cancer Center-West Lakes, Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive
Greater Regional Medical Center, Creston
Blank Children's Hospital, Des Moines
Broadlawns Medical Center, Des Moines
Iowa Methodist Medical Center, Des Moines
Mercy Medical Center - Des Moines, Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines
UI Healthcare Mission Cancer and Blood - Fort Dodge, Fort Dodge
University of Iowa/Holden Comprehensive Cancer Center, Iowa City
UI Healthcare Mission Cancer and Blood - Pella, Pella
UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee
Mercy Medical Center-West Lakes, West Des Moines
The Iowa Clinic PC, West Des Moines
KansasCentral Care Cancer Center - Garden City, Garden City
Central Care Cancer Center - Great Bend, Great Bend
KentuckyNorton Children's Hospital, Louisville
LouisianaChildren's Hospital New Orleans, New Orleans
Ochsner Medical Center Jefferson, New Orleans
MaineMaine Children's Cancer Program, Scarborough
MaineHealth Maine Medical Center- Scarborough, Scarborough
MarylandWalter Reed National Military Medical Center, Bethesda
Christiana Care - Union Hospital, Elkton
MichiganC S Mott Children's Hospital, Ann Arbor
University of Michigan Rogel Cancer Center, Ann Arbor
Bronson Battle Creek, Battle Creek
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Trinity Health Grand Rapids Hospital, Grand Rapids
Beacon Kalamazoo, Kalamazoo
Beacon Kalamazoo Cancer Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
Trinity Health Muskegon Hospital, Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Corewell Health Reed City Hospital, Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
Munson Medical Center, Traverse City
University of Michigan Health - West, Wyoming
MinnesotaChildren's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis
University of Minnesota/Masonic Cancer Center, Minneapolis
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriMercy Oncology and Hematology - Clayton-Clarkson, Ballwin
Central Care Cancer Center - Bolivar, Bolivar
Cox Cancer Center Branson, Branson
Mercy Cancer Center - Cape Girardeau, Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Freeman Health System, Joplin
Mercy Hospital Joplin, Joplin
Children's Mercy Hospitals and Clinics, Kansas City
Lake Regional Hospital, Osage Beach
Mercy Clinic-Rolla-Cancer and Hematology, Rolla
Phelps Health Delbert Day Cancer Institute, Rolla
Heartland Regional Medical Center, Saint Joseph
CoxHealth South Hospital, Springfield
Mercy Hospital Springfield, Springfield
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
Mercy Infusion Center - Chippewa, St Louis
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
Mercy Hospital Washington, Washington
NebraskaChildren's Hospital and Medical Center of Omaha, Omaha
University of Nebraska Medical Center, Omaha
New JerseyHackensack University Medical Center, Hackensack
New MexicoPresbyterian Hospital, Albuquerque
University of New Mexico Cancer Center, Albuquerque
New YorkAlbany Medical Center, Albany
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York
NYP/Weill Cornell Medical Center, New York
University of Rochester, Rochester
Stony Brook University Medical Center, Stony Brook
Montefiore Medical Center - Moses Campus, The Bronx
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
Duke University Medical Center, Durham
Wake Forest University Health Sciences, Winston-Salem
North DakotaSanford Bismarck Medical Center, Bismarck
Sanford Broadway Medical Center, Fargo
OhioChildren's Hospital Medical Center of Akron, Akron
Cleveland Clinic Foundation, Cleveland
Nationwide Children's Hospital, Columbus
Dayton Children's Hospital, Dayton
OklahomaMercy Hospital Oklahoma City, Oklahoma City
University of Oklahoma Health Sciences Center, Oklahoma City
OregonOregon Health and Science University, Portland
PennsylvaniaChristiana Care Health System-Concord Health Center, Chadds Ford
Penn State Children's Hospital, Hershey
Children's Hospital of Philadelphia, Philadelphia
Saint Christopher's Hospital for Children, Philadelphia
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
Rhode IslandRhode Island Hospital, Providence
South CarolinaMedical University of South Carolina, Charleston
Prisma Health Richland Hospital, Columbia
South DakotaSanford USD Medical Center - Sioux Falls, Sioux Falls
TennesseeSaint Jude Children's Research Hospital, Memphis
The Children's Hospital at TriStar Centennial, Nashville
Vanderbilt University/Ingram Cancer Center, Nashville
TexasMedical City Dallas Hospital, Dallas
Parkland Memorial Hospital, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
El Paso Children's Hospital, El Paso
Cook Children's Medical Center, Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston
UT MD Anderson Cancer Center, Houston
Children's Hospital of San Antonio, San Antonio
VirginiaVCU Massey Comprehensive Cancer Center, Richmond
Carilion Children's, Roanoke
WashingtonFred Hutchinson Cancer Center, Seattle
Seattle Children's Hospital, Seattle
University of Washington Medical Center - Montlake, Seattle
Providence Sacred Heart Medical Center and Children's Hospital, Spokane
Madigan Army Medical Center, Tacoma
WisconsinSaint Vincent Hospital Cancer Center Green Bay, Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Aurora Sinai Medical Center, Milwaukee
Children's Hospital of Wisconsin, Milwaukee
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls
Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan
Sheboygan Physicians Group, Sheboygan
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.