Assessment of the Effect of a Co-treatment With GnRH Analogs on the Ovarian Reserve in Adolescents and Young Women Treated With Alkylating Agents for Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Variation in AMH serum levels between both groups
研究概览
简要总结
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.
详细描述
This is a French, Prospective, Multicentre, Open, Randomised study To determine the efficacy of a temporary ovarian suppression obtained by administration of a Gonadotropin Releasing Hormone agonist (GnRHa) on maintaining ovarian reserve, patients will be randomized, half of them receiving Triptorelin extended release (LP) 3 mg intramuscularly every 28±3 days, starting at the inclusion visit and at least 72 days before chemotherapy with alkylating agents until 1 month after end of chemotherapy (mean duration: 12 months).
The primary objective of the study is to determine the effect of a temporary ovarian suppression achieved through administration of a gonadotropin releasing hormone agonist (triptorelin LP 3 mg) during alkylating agents containing chemotherapy on ovarian reserve assessed by AMH serum levels in adolescents and young women with cancer.
Number of centres 19 Research period
- Recruitment duration 2 years
- The duration of participation of each patient is: 3 years
- The duration of the treatment period is: 1 year
- The duration of the follow-up period is: 2 years
- Total duration: 5 years
Statistical analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prepubertal
- •Planned brain or pelvic radiotherapy
- •Planned stem cell transplantation
- •Ovariectomy
- •Having already received chemotherapy with alkylating agents
- •Hypersensitivity to any component of GnRHa
研究组 & 干预措施
Triptorelin (GnRHa) + Chemotherapy
Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy
干预措施: Triptorelin (GnRHa) + Chemotherapy (Drug)
结局指标
主要结局
Variation in AMH serum levels between both groups
时间窗: at 24 months
Centralised hormonal dosages
次要结局
- Number of patients with AMH serum levels < 5th percentile in each group(at 24 months)
- Intra-patient variation in AMH serum levels between groups(up to 36 months)
- Antral Follicular Count (AFC) on ultrasound between the 2 groups(at month 24)
- Relative change in Bone Mass Density (BMD) of the lumbar spine, left femoral neck and whole body in the 2 groups(at the baseline and at month 12 and month 36)
- Levels of markers of ovarian reserve: AMH, Follicle-stimulating hormone (FSH), Estradiol between groups(at months 12, 24 and 36)
- Delay of resumption of menses between the 2 groups(up to the end of the follow up (an average of 3 years))
- Pregnancy rate in the 2 groups(up to the end of the follow up (an average of 3 years))
- Adverse events related to Triptorelin co-treatment(up to the end of the follow up (an average of 3 years))