Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

Sun Yat-sen University602 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

602

Conditions

Nasopharyngeal Carcinoma

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis 2. Age between 18-45, female 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 4. 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) . 5. Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value. 6. No history of infertility. 7. No history of hysterectomy or bilateral ovariectomy. 8. Patient have signed on the informed consent, and well understood the objective and procedure of this study Exclusion Criteria: 1. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx. 2. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 3. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 4. Patients with severe dysfunction of heart, liver, lung, kidney or marrow. 5. Patients with severe, uncontrolled disease or infections. 6. Refuse or fail to sign the informed consent . 7. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Premature Ovarian Failure (POF)

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.

Time frame: 3 years after Radiotherapy

Secondary Outcomes

Progress-Free Survival (PFS)

Progress-free survival is calculated from the date of registration to the date of the first progress at any site.

Time frame: 3 years after Radiotherapy

Pregnancy and birth outcome

The pregnancy history and pregnancy outcome of female Nasopharyngeal carcinoma (NPC) patients before diagnosis of NPC would be investigate Within 6 months of diagnosis. The pregnancy events and birth outcome of female NPC patients after diagnosis of NPC would be investigate among 3 to 5years after Radiotherapy.

Time frame: Within 6 month of diagnosis, or 3-5years after Radiotherapy

Overall Survival (OS)

The Overall Survival (OS) was defined as the duration from the date of registration assignment to the date of death from any cause or censored at the date of the last follow-up.

Time frame: 3 years after Radiotherapy

Locoregional Relapse-Free Survival (LRFS)

The Locoregional Relapse-Free Survival (LRFS) is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit

Time frame: 3 years after Radiotherapy

Distant Metastasis-Free Survival (DMFS)

The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit.

Central Contacts

Haiqiang Mai, MD, PhD

CONTACT

86-20-8734-3643 maihq@sysucc.org.cn

Qiuyan Chen, MD, PhD

CONTACT

86-20-8734-3380 chenqy@sysucc.org.cn

Data from ClinicalTrials.gov

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