Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT05183724
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2019-02-16
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study Start: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2025-01-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 602

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Premature Ovarian Failure (POF)	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 Outcome Measures

Name	Time	Method
Distant Metastasis-Free Survival (DMFS)	3 years after Radiotherapy	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.
Locoregional Relapse-Free Survival (LRFS)	3 years after Radiotherapy	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
Progress-Free Survival (PFS)	3 years after Radiotherapy	Progress-free survival is calculated from the date of registration to the date of the first progress at any site.
Pregnancy and birth outcome	Within 6 month of diagnosis, or 3-5years after Radiotherapy	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.
Overall Survival (OS)	3 years after Radiotherapy	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.

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China