Triptorelin for Cancer

Recruiting at 79 trial locations

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Must not be taking: Depot GnRH agonists

Disqualifiers: Pelvic radiation, Bilateral oophorectomy, Congenital infertility syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24-48 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 an 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.

Who Is on the Research Team?

Eric J Chow

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for post-menarchal females under 40 years old, diagnosed with their first cancer (excluding breast cancer), who will receive chemotherapy including alkylating agents. They must have had their first menstrual period over 6 months ago and agree to consent forms. It's not suitable for those who don't meet these criteria or can't follow the study requirements.

Inclusion Criteria

I meet all legal and institutional requirements for participating in human studies.

I am under 40 years old.

My treatment plan includes specific chemotherapy drugs aimed at curing my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive triptorelin intramuscularly 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.

24-48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of ovarian reserve and hormone levels up to 2 years post-chemotherapy.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Triptorelin

Trial Overview The trial tests if Triptorelin can prevent ovarian damage in young female cancer patients during chemotherapy. Participants are either given Triptorelin or no treatment as a comparison, alongside standard chemo with alkylating agents known to affect ovaries.

How Is the Trial Designed?

Group I: Arm A (triptorelin) Experimental Treatment 4 Interventions

Patients receive triptorelin 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.

Group II: Arm B (usual care) Active Control 4 Interventions

Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+