Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 602
- Locations
- 1
- Primary Endpoint
- Premature Ovarian Failure (POF)
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Hai-Qiang Mai,MD,PhD
Chief Physician
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Premature Ovarian Failure (POF)
Time Frame: 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.
Secondary Outcomes
- 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)