RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Children's Oncology Group • ClinicalTrials.gov ID: NCT06513962

Registry updated: 2026-08-31

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Description

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.

Interventions

Best Practice (Other)
Receive standard chemotherapy
Biospecimen Collection (Procedure)
Undergo blood sample collection
Electronic Health Record Review (Other)
Ancillary studies
Survey Administration (Other)
Ancillary studies
Triptorelin Pamoate (Drug)
Given IM

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).

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Locations

Children's Hospital of Alabama — Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
USA Health Strada Patient Care Center — Mobile, Alabama, United States
Phoenix Childrens Hospital — Phoenix, Arizona, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
CARTI Cancer Center — Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Mattel Children's Hospital UCLA — Los Angeles, California, United States
Kaiser Permanente-Oakland — Oakland, California, United States
Children's Hospital of Orange County — Orange, California, United States
Sutter Medical Center Sacramento — Sacramento, California, United States
UC San Diego Medical Center - Hillcrest — San Diego, California, United States
Rady Children's Hospital - San Diego — San Diego, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Beebe Medical Center — Lewes, Delaware, United States
Beebe South Coastal Health Campus — Millville, Delaware, United States
Helen F Graham Cancer Center — Newark, Delaware, United States
Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
Beebe Health Campus — Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
Nicklaus Children's Hospital — Miami, Florida, United States
Miami Cancer Institute — Miami, Florida, United States
AdventHealth Orlando — Orlando, Florida, United States
Nemours Children's Hospital — Orlando, Florida, United States
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
Tampa General Hospital — Tampa, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
Saint Mary's Medical Center — West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
OSF Saint Anthony's Health Center — Alton, Illinois, United States
Rush-Copley Medical Center — Aurora, Illinois, United States
Saint Mary's Hospital — Centralia, Illinois, United States
Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
Northwestern University — Chicago, Illinois, United States
University of Illinois — Chicago, Illinois, United States
Carle at The Riverfront — Danville, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
Carle Physician Group-Effingham — Effingham, Illinois, United States
Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States
Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
SSM Health Good Samaritan — Mount Vernon, Illinois, United States
Carle BroMenn Medical Center — Normal, Illinois, United States
Carle Cancer Institute Normal — Normal, Illinois, United States
Advocate Children's Hospital-Oak Lawn — Oak Lawn, Illinois, United States
Northwestern Medicine Orland Park — Orland Park, Illinois, United States
Advocate Children's Hospital-Park Ridge — Park Ridge, Illinois, United States
Memorial Hospital East — Shiloh, Illinois, United States
Saint John's Hospital — Springfield, Illinois, United States
Southern Illinois University School of Medicine — Springfield, Illinois, United States
Carle Cancer Center — Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
Rush-Copley Healthcare Center — Yorkville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
Riley Hospital for Children — Indianapolis, Indiana, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
Saint Anthony Regional Hospital — Carroll, Iowa, United States
Mercy Cancer Center-West Lakes — Clive, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
Greater Regional Medical Center — Creston, Iowa, United States
Blank Children's Hospital — Des Moines, Iowa, United States
Iowa Methodist Medical Center — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
Broadlawns Medical Center — Des Moines, Iowa, United States
Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge — Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
UI Healthcare Mission Cancer and Blood - Pella — Pella, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
Mercy Medical Center-West Lakes — West Des Moines, Iowa, United States
The Iowa Clinic PC — West Des Moines, Iowa, United States
Central Care Cancer Center - Garden City — Garden City, Kansas, United States
Central Care Cancer Center - Great Bend — Great Bend, Kansas, United States
Norton Children's Hospital — Louisville, Kentucky, United States
Children's Hospital New Orleans — New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
Maine Children's Cancer Program — Scarborough, Maine, United States
MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Christiana Care - Union Hospital — Elkton, Maryland, United States
C S Mott Children's Hospital — Ann Arbor, Michigan, United States
University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
Bronson Battle Creek — Battle Creek, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital — Grand Rapids, Michigan, United States
Bronson Methodist Hospital — Kalamazoo, Michigan, United States
West Michigan Cancer Center — Kalamazoo, Michigan, United States
Beacon Kalamazoo Cancer Center — Kalamazoo, Michigan, United States
Beacon Kalamazoo — Kalamazoo, Michigan, United States
Trinity Health Muskegon Hospital — Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital — Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores — Norton Shores, Michigan, United States
Corewell Health Reed City Hospital — Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital — Saint Joseph, Michigan, United States
Munson Medical Center — Traverse City, Michigan, United States
University of Michigan Health - West — Wyoming, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Mercy Oncology and Hematology - Clayton-Clarkson — Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar — Bolivar, Missouri, United States
Cox Cancer Center Branson — Branson, Missouri, United States
Mercy Cancer Center - Cape Girardeau — Cape Girardeau, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
Freeman Health System — Joplin, Missouri, United States
Mercy Hospital Joplin — Joplin, Missouri, United States
Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
Lake Regional Hospital — Osage Beach, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology — Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute — Rolla, Missouri, United States
Heartland Regional Medical Center — Saint Joseph, Missouri, United States
Mercy Hospital Springfield — Springfield, Missouri, United States
CoxHealth South Hospital — Springfield, Missouri, United States
Mercy Infusion Center - Chippewa — St Louis, Missouri, United States
Washington University School of Medicine — St Louis, Missouri, United States
Mercy Hospital South — St Louis, Missouri, United States
Siteman Cancer Center-South County — St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
Mercy Hospital Saint Louis — St Louis, Missouri, United States
Mercy Hospital Washington — Washington, Missouri, United States
Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Presbyterian Hospital — Albuquerque, New Mexico, United States
University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
Albany Medical Center — Albany, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
NYP/Weill Cornell Medical Center — New York, New York, United States
University of Rochester — Rochester, New York, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
Sanford Broadway Medical Center — Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron — Akron, Ohio, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
Dayton Children's Hospital — Dayton, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City — Oklahoma City, Oklahoma, United States
Oregon Health and Science University — Portland, Oregon, United States
Christiana Care Health System-Concord Health Center — Chadds Ford, Pennsylvania, United States
Penn State Children's Hospital — Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Prisma Health Richland Hospital — Columbia, South Carolina, United States
Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
Saint Jude Children's Research Hospital — Memphis, Tennessee, United States
The Children's Hospital at TriStar Centennial — Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
Medical City Dallas Hospital — Dallas, Texas, United States
Parkland Memorial Hospital — Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
El Paso Children's Hospital — El Paso, Texas, United States
Cook Children's Medical Center — Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
UT MD Anderson Cancer Center — Houston, Texas, United States
Children's Hospital of San Antonio — San Antonio, Texas, United States
VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
Carilion Children's — Roanoke, Virginia, United States
Seattle Children's Hospital — Seattle, Washington, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States
University of Washington Medical Center - Montlake — Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
Madigan Army Medical Center — Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's — Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center — Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls — Oconto Falls, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan — Sheboygan, Wisconsin, United States
Sheboygan Physicians Group — Sheboygan, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay — Sturgeon Bay, Wisconsin, United States
CancerCare Manitoba — Winnipeg, Manitoba, Canada
The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont — Sherbrooke, Quebec, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) — Québec, Canada

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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