Using triptorelin to protect ovaries in young cancer patients during chemotherapy
Official title: Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer
Run by Children's Oncology Group · NCT06513962 · Data updated 2026-11-12
This study is testing if triptorelin can help protect the ovaries of young cancer patients under 40 during chemotherapy to see if it helps maintain their fertility and overall health later on.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 39 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Children's Oncology Group Research network |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide |
| Locations | 206 sites (Birmingham, Alabama and 205 other locations) |
| Status | Recruiting |
| Started | February 27, 2025 |
| Main results expected | October 30, 2029 |
| Study ends | October 30, 2029 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT06513962 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are post-menarchal females under 40 years old, newly diagnosed with cancer (excluding breast cancer), and scheduled to receive alkylating agent chemotherapy.
✕Probably not a fit
Patients who are over 40 years old or have a history of breast cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial investigates the effectiveness of triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) under 40 years old who are newly diagnosed with cancer and receiving chemotherapy with alkylating agents. Participants are randomly assigned to receive either triptorelin or no triptorelin before starting chemotherapy. The study aims to measure ovarian reserve through anti-Mullerian hormone (AMH) levels two years after treatment and to assess the long-term reproductive health of participants. Additionally, the trial will evaluate the feasibility of tracking estrogen deprivation symptoms and quality of life among the participants.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infertility in young cancer patients undergoing chemotherapy.
How similar studies have gone: Previous studies have shown promise in using hormonal treatments to protect ovarian function during chemotherapy, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Children's Hospital of Alabama
Birmingham, Alabama, United States Recruiting -
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Recruiting -
USA Health Strada Patient Care Center
Mobile, Alabama, United States Recruiting -
Phoenix Childrens Hospital
Phoenix, Arizona, United States Recruiting -
Banner University Medical Center - Tucson
Tucson, Arizona, United States Recruiting -
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States Recruiting
Show 44 more locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States Recruiting -
CARTI Cancer Center
Little Rock, Arkansas, United States Recruiting -
City of Hope Comprehensive Cancer Center
Duarte, California, United States Recruiting -
UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
Loma Linda University Medical Center
Loma Linda, California, United States Recruiting -
Mattel Children's Hospital UCLA
Los Angeles, California, United States Recruiting -
Kaiser Permanente-Oakland
Oakland, California, United States Recruiting -
Children's Hospital of Orange County
Orange, California, United States Recruiting -
Sutter Medical Center Sacramento
Sacramento, California, United States Recruiting -
Rady Children's Hospital - San Diego
San Diego, California, United States Recruiting -
Children's Hospital Colorado
Aurora, Colorado, United States Recruiting -
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States Recruiting -
Connecticut Children's Medical Center
Hartford, Connecticut, United States Recruiting -
Beebe Medical Center
Lewes, Delaware, United States Recruiting -
Beebe South Coastal Health Campus
Millville, Delaware, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States Recruiting -
Beebe Health Campus
Rehoboth Beach, Delaware, United States Recruiting -
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States Recruiting -
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States Recruiting -
Children's National Medical Center
Washington D.C., District of Columbia, United States Recruiting -
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States Recruiting -
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States Recruiting -
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States Recruiting -
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
Nicklaus Children's Hospital
Miami, Florida, United States Recruiting -
Miami Cancer Institute
Miami, Florida, United States Recruiting -
AdventHealth Orlando
Orlando, Florida, United States Recruiting -
Nemours Children's Hospital
Orlando, Florida, United States Recruiting -
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States Recruiting -
Tampa General Hospital
Tampa, Florida, United States Recruiting -
Saint Mary's Medical Center
West Palm Beach, Florida, United States Recruiting -
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States Recruiting -
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States Recruiting -
OSF Saint Anthony's Health Center
Alton, Illinois, United States Recruiting -
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
University of Illinois
Chicago, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States Recruiting -
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States Recruiting -
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States Recruiting
+156 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Eric J Chow — Children's Oncology Group
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.