Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 602
- 试验地点
- 1
- 主要终点
- Premature Ovarian Failure (POF)
研究概览
简要总结
This is an observational cohort study aimed to explore the fertility concerns, fertility preservation strategies, fertility status (pregnancy and Ovarian Failure) and birth outcome among young woman Nasopharyngeal carcinoma patients.
详细描述
The purpose of this study was to explore the effects of radiotherapy and chemotherapy on ovarian function and pregnancy outcome after treatment in female survivors of non-metastatic nasopharyngeal carcinoma, so as to clarify the relationship between ovarian dysfunction after treatment and pregnancy outcome, as well as clarify the relationship between pregnancy after treatment and tumour progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis
- •Age between 18-45, female
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .
- •Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
- •No history of infertility.
- •No history of hysterectomy or bilateral ovariectomy.
- •Patient have signed on the informed consent, and well understood the objective and procedure of this study
排除标准
- •Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
- •Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
- •Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
- •Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
- •Patients with severe, uncontrolled disease or infections.
- •Refuse or fail to sign the informed consent .
- •Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
结局指标
主要结局
Premature Ovarian Failure (POF)
时间窗: 3 years after Radiotherapy
Premature Ovarian Failure (POF) was defined as menopause before age 40 years. Menopause was defined as cessation of menstruation at least 1 year before the date of the survey in the absence of pregnancy, breastfeeding, continuous use of progestagens or other medication causing amenorrhea, or surgical removal of uterus and/ or ovaries.
次要结局
- Distant Metastasis-Free Survival (DMFS)(3 years after Radiotherapy)
- Locoregional Relapse-Free Survival (LRFS)(3 years after Radiotherapy)
- Progress-Free Survival (PFS)(3 years after Radiotherapy)
- Pregnancy and birth outcome(Within 6 month of diagnosis, or 3-5years after Radiotherapy)
- Overall Survival (OS)(3 years after Radiotherapy)
研究者
Hai-Qiang Mai,MD,PhD
Chief Physician
Sun Yat-sen University