Clinical trial Recruiting at 196 sites Phase 3 Interventional Ages Any age to 39 Women only

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.

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Quick facts

PhasePhase 3
Study typeInterventional
AgesAny age to 39 Years
SexWomen only
Enrollment60 (estimated)
SponsorChildren's Oncology Group
Research network
Drugs / interventionschemotherapy, radiation, cyclophosphamide
Locations206 sites (Birmingham, Alabama and 205 other locations)
StatusRecruiting
StartedFebruary 27, 2025
Main results expectedOctober 30, 2029
Study endsOctober 30, 2029
Registry record updatedAugust 31, 2026
Trial IDNCT06513962 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

  • 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
  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.