Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer

• Status: Active, not recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

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-Müllerian hormone (AMH) serum levels in adolescents and young women with cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Alkylating Agents; Deslorelin; Triptorelin Pamoate

Criteria

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