Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agen… (NCT02856048) | Clinical Trial Compass
UnknownPhase 2/3
Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
France11 participantsStarted 2016-11-23
Plain-language summary
The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-MĂĽllerian hormone (AMH) serum levels in adolescents and young women with cancer.
Who can participate
Age range12 Years – 25 Years
SexFEMALE
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Inclusion Criteria:
* Female aged 12 to 25 years
* Puberty Tanner 2 or more
* Diagnosis of cancer: Sarcoma, Ewing, Osteosarcoma, Lymphoma
* Chemotherapy protocol with alkylating agents at an intermediate ovarian toxicity risk (Cyclophosphamide 6 g/m2, Ifosfamide 50 g/m2, Procarbazine 4 g/m2, Lomustine 350 mg/m2 or Melphalan 140 mg/m2 or a combination of these drugs).
* All patients with an osteosarcoma, Ewing sarcoma excepted pelvic localisation, Hodgkin lymphoma treatment group III (stages II B, III B and IV), B cell lymphoma group C, rhabdomyosarcoma treated with at least 8 Ifosfamide Vincristin Actinomycin (IVA) courses, synoviosarcoma group II T\>5 cm and group III, adult type sarcoma group I and II T\>5 cm and group III.
* Before starting any chemotherapy
* Covered by a medical insurance
Exclusion Criteria:
* Prepubertal
* Pregnant
* Planned brain or pelvic radiotherapy
* Planned stem cell transplantation
* Ovariectomy
* Having already received chemotherapy with alkylating agents
* Hypersensitivity to any component of GnRHa