Use of GnRHa During Chemotherapy for Fertility Protection
Recruiting
Phase 3
Interventional Study
Breast Cancer Female
Acute Leukemia
Lymphoma
Osteosarcoma
Soft Tissue Sarcoma
Ewing Sarcoma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 – 42
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Kenny Rodriguez-Wallberg · Other
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About This Trial
Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects.
Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent
* Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
* Confirmed menarche
* ECOG performance status 0-1
* Adequate bone …
Contacts