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Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
NCT06513962 · Children's Oncology Group
In plain English
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Official title
Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
About this study
PRIMARY OBJECTIVES:
I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age \< 40 years (exclusive of breast cancer).
II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients.
SECONDARY OBJECTIVES:
I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients.
II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients.
EXPLORATORY OBJECTIVE:
I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 1 and 2 years.
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.
* For patients \< 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED.
* 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.
* Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted 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).
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-02-27
Estimated completion: 2029-10-30
Last updated: 2026-02-24
Interventions
Other: Best PracticeProcedure: Biospecimen CollectionOther: Electronic Health Record ReviewOther: Survey AdministrationDrug: Triptorelin Pamoate
Primary outcomes
- • Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years (Up to 2 years post-chemotherapy)
- • Accrual rates of newly diagnosed AYA female cancer patients age < 40 years (Up to 2 years post-chemotherapy)
- • Anti-mullerian hormone (AMH) levels (At 2 years post-chemotherapy)
Sponsor
Children's Oncology Group · network
Contacts & investigators
InvestigatorEric J Chow · principal_investigator, Children's Oncology Group
All locations (187)
Children's Hospital of AlabamaRecruiting
Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer CenterRecruiting
Birmingham, Alabama, United States
Phoenix Childrens HospitalRecruiting
Phoenix, Arizona, United States
Mercy Hospital Fort SmithRecruiting
Fort Smith, Arkansas, United States
Arkansas Children's HospitalRecruiting
Little Rock, Arkansas, United States
CARTI Cancer CenterRecruiting
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
Loma Linda University Medical CenterRecruiting
Loma Linda, California, United States
Mattel Children's Hospital UCLARecruiting
Los Angeles, California, United States
Kaiser Permanente-OaklandRecruiting
Oakland, California, United States
Children's Hospital of Orange CountyRecruiting
Orange, California, United States
Sutter Medical Center SacramentoRecruiting
Sacramento, California, United States
UC San Diego Medical Center - HillcrestSuspended
San Diego, California, United States
Rady Children's Hospital - San DiegoRecruiting
San Diego, California, United States
Children's Hospital ColoradoRecruiting
Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterRecruiting
Denver, Colorado, United States
Connecticut Children's Medical CenterRecruiting
Hartford, Connecticut, United States
Beebe Medical CenterRecruiting
Lewes, Delaware, United States
Beebe South Coastal Health CampusRecruiting
Millville, Delaware, United States
Helen F Graham Cancer CenterRecruiting
Newark, Delaware, United States
Medical Oncology Hematology Consultants PARecruiting
Newark, Delaware, United States
Christiana Care Health System-Christiana HospitalRecruiting
Newark, Delaware, United States
Beebe Health CampusRecruiting
Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington HospitalRecruiting
Wilmington, Delaware, United States
Alfred I duPont Hospital for ChildrenRecruiting
Wilmington, Delaware, United States
Children's National Medical CenterRecruiting
Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest FloridaRecruiting
Fort Myers, Florida, United States
UF Health Cancer Institute - GainesvilleRecruiting
Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
Hollywood, Florida, United States
Nemours Children's Clinic-JacksonvilleRecruiting
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
Miami, Florida, United States
Nicklaus Children's HospitalRecruiting
Miami, Florida, United States
Miami Cancer InstituteRecruiting
Miami, Florida, United States
Nemours Children's HospitalRecruiting
Orlando, Florida, United States
Nemours Children's Clinic - PensacolaRecruiting
Pensacola, Florida, United States
Tampa General HospitalRecruiting
Tampa, Florida, United States
Saint Joseph's Hospital/Children's Hospital-TampaActive Not Recruiting
Tampa, Florida, United States
Saint Mary's Medical CenterRecruiting
West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank HospitalRecruiting
Atlanta, Georgia, United States
Kapiolani Medical Center for Women and ChildrenRecruiting
Honolulu, Hawaii, United States
OSF Saint Anthony's Health CenterRecruiting
Alton, Illinois, United States
Rush-Copley Medical CenterSuspended
Aurora, Illinois, United States
Saint Mary's HospitalSuspended
Centralia, Illinois, United States
Lurie Children's Hospital-ChicagoRecruiting
Chicago, Illinois, United States
University of IllinoisRecruiting
Chicago, Illinois, United States
Carle at The RiverfrontSuspended
Danville, Illinois, United States
Carle Physician Group-EffinghamSuspended
Effingham, Illinois, United States
Carle Physician Group-Mattoon/CharlestonSuspended
Mattoon, Illinois, United States
SSM Health Good SamaritanRecruiting
Mount Vernon, Illinois, United States
Carle BroMenn Medical CenterRecruiting
Normal, Illinois, United States
Carle Cancer Institute NormalRecruiting
Normal, Illinois, United States
Advocate Children's Hospital-Oak LawnRecruiting
Oak Lawn, Illinois, United States
Advocate Children's Hospital-Park RidgeRecruiting
Park Ridge, Illinois, United States
Memorial Hospital EastRecruiting
Shiloh, Illinois, United States
Saint John's HospitalRecruiting
Springfield, Illinois, United States
Southern Illinois University School of MedicineRecruiting
Springfield, Illinois, United States
Carle Cancer CenterSuspended
Urbana, Illinois, United States
Rush-Copley Healthcare CenterSuspended
Yorkville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
Riley Hospital for ChildrenRecruiting
Indianapolis, Indiana, United States
UI Health Care Mission Cancer and Blood - Ankeny ClinicRecruiting
Ankeny, Iowa, United States
Saint Anthony Regional HospitalRecruiting
Carroll, Iowa, United States
Mercy Cancer Center-West LakesRecruiting
Clive, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines ClinicRecruiting
Clive, Iowa, United States
Greater Regional Medical CenterRecruiting
Creston, Iowa, United States
Blank Children's HospitalRecruiting
Des Moines, Iowa, United States
Iowa Methodist Medical CenterRecruiting
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines ClinicRecruiting
Des Moines, Iowa, United States
Broadlawns Medical CenterRecruiting
Des Moines, Iowa, United States
Mercy Medical Center - Des MoinesRecruiting
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel ClinicRecruiting
Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - Fort DodgeRecruiting
Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer CenterRecruiting
Iowa City, Iowa, United States
UI Healthcare Mission Cancer and Blood - PellaRecruiting
Pella, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee ClinicRecruiting
Waukee, Iowa, United States
Mercy Medical Center-West LakesRecruiting
West Des Moines, Iowa, United States
The Iowa Clinic PCRecruiting
West Des Moines, Iowa, United States
Central Care Cancer Center - Garden CityRecruiting
Garden City, Kansas, United States
Central Care Cancer Center - Great BendRecruiting
Great Bend, Kansas, United States
Norton Children's HospitalRecruiting
Louisville, Kentucky, United States
Children's Hospital New OrleansRecruiting
New Orleans, Louisiana, United States
Ochsner Medical Center JeffersonRecruiting
New Orleans, Louisiana, United States
Maine Children's Cancer ProgramRecruiting
Scarborough, Maine, United States
MaineHealth Maine Medical Center- ScarboroughRecruiting
Scarborough, Maine, United States
Walter Reed National Military Medical CenterRecruiting
Bethesda, Maryland, United States
Christiana Care - Union HospitalRecruiting
Elkton, Maryland, United States
C S Mott Children's HospitalRecruiting
Ann Arbor, Michigan, United States
University of Michigan Rogel Cancer CenterSuspended
Ann Arbor, Michigan, United States
Bronson Battle CreekRecruiting
Battle Creek, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth HospitalRecruiting
Grand Rapids, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalRecruiting
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids HospitalRecruiting
Grand Rapids, Michigan, United States
Bronson Methodist HospitalRecruiting
Kalamazoo, Michigan, United States
West Michigan Cancer CenterRecruiting
Kalamazoo, Michigan, United States
Beacon Kalamazoo Cancer CenterRecruiting
Kalamazoo, Michigan, United States
Beacon KalamazooRecruiting
Kalamazoo, Michigan, United States
Trinity Health Muskegon HospitalRecruiting
Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles HospitalRecruiting
Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
Norton Shores, Michigan, United States
Corewell Health Reed City HospitalRecruiting
Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterRecruiting
Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph HospitalRecruiting
Saint Joseph, Michigan, United States
Munson Medical CenterRecruiting
Traverse City, Michigan, United States
University of Michigan Health - WestRecruiting
Wyoming, Michigan, United States
Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer CenterRecruiting
Minneapolis, Minnesota, United States
University of Mississippi Medical CenterRecruiting
Jackson, Mississippi, United States
Mercy Oncology and Hematology - Clayton-ClarksonRecruiting
Ballwin, Missouri, United States
Central Care Cancer Center - BolivarRecruiting
Bolivar, Missouri, United States
Cox Cancer Center BransonRecruiting
Branson, Missouri, United States
Mercy Cancer Center - Cape GirardeauRecruiting
Cape Girardeau, Missouri, United States
Siteman Cancer Center at Saint Peters HospitalRecruiting
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County HospitalRecruiting
Creve Coeur, Missouri, United States
Freeman Health SystemRecruiting
Joplin, Missouri, United States
Mercy Hospital JoplinRecruiting
Joplin, Missouri, United States
Children's Mercy Hospitals and ClinicsRecruiting
Kansas City, Missouri, United States
Lake Regional HospitalRecruiting
Osage Beach, Missouri, United States
Mercy Clinic-Rolla-Cancer and HematologyRecruiting
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer InstituteRecruiting
Rolla, Missouri, United States
Heartland Regional Medical CenterRecruiting
Saint Joseph, Missouri, United States
Mercy Hospital SpringfieldRecruiting
Springfield, Missouri, United States
CoxHealth South HospitalRecruiting
Springfield, Missouri, United States
Mercy Infusion Center - ChippewaRecruiting
St Louis, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Mercy Hospital SouthRecruiting
St Louis, Missouri, United States
Siteman Cancer Center-South CountyRecruiting
St Louis, Missouri, United States
Siteman Cancer Center at Christian HospitalRecruiting
St Louis, Missouri, United States
Mercy Hospital Saint LouisRecruiting
St Louis, Missouri, United States
Mercy Hospital WashingtonRecruiting
Washington, Missouri, United States
Children's Hospital and Medical Center of OmahaRecruiting
Omaha, Nebraska, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Presbyterian HospitalRecruiting
Albuquerque, New Mexico, United States
University of New Mexico Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Albany Medical CenterRecruiting
Albany, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
New York, New York, United States
NYP/Weill Cornell Medical CenterRecruiting
New York, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
Stony Brook University Medical CenterRecruiting
Stony Brook, New York, United States
Montefiore Medical Center - Moses CampusRecruiting
The Bronx, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of AkronRecruiting
Akron, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Nationwide Children's HospitalRecruiting
Columbus, Ohio, United States
Dayton Children's HospitalRecruiting
Dayton, Ohio, United States
University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma CityRecruiting
Oklahoma City, Oklahoma, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Christiana Care Health System-Concord Health CenterRecruiting
Chadds Ford, Pennsylvania, United States
Penn State Children's HospitalRecruiting
Hershey, Pennsylvania, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for ChildrenRecruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
Prisma Health Richland HospitalRecruiting
Columbia, South Carolina, United States
Saint Jude Children's Research HospitalRecruiting
Memphis, Tennessee, United States
The Children's Hospital at TriStar CentennialRecruiting
Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
Medical City Dallas HospitalRecruiting
Dallas, Texas, United States
Parkland Memorial HospitalRecruiting
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-DallasRecruiting
Dallas, Texas, United States
El Paso Children's HospitalRecruiting
El Paso, Texas, United States
Cook Children's Medical CenterRecruiting
Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
Houston, Texas, United States
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
Children's Hospital of San AntonioRecruiting
San Antonio, Texas, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Carilion Children'sRecruiting
Roanoke, Virginia, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University of Washington Medical Center - MontlakeRecruiting
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's HospitalRecruiting
Spokane, Washington, United States
Madigan Army Medical CenterRecruiting
Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green BayRecruiting
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterRecruiting
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University HospitalRecruiting
Madison, Wisconsin, United States
Children's Hospital of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Aurora Sinai Medical CenterRecruiting
Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
Oconto Falls, Wisconsin, United States
Saint Vincent Hospital Cancer Center at SheboyganRecruiting
Sheboygan, Wisconsin, United States
Sheboygan Physicians GroupRecruiting
Sheboygan, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
Sturgeon Bay, Wisconsin, United States
CancerCare ManitobaRecruiting
Winnipeg, Manitoba, Canada
The Montreal Children's Hospital of the MUHCRecruiting
Montreal, Quebec, Canada