Clinical trial NCT05183724: Ovarian Function of Nasopharyngeal Carcinoma Women Survivors
Official title: Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
ovarian function
Pregnancy outcomes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 602
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female NPC patients (18 to 45 years old)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Premature Ovarian Failure (POF)
timeFrame: 3 years after Radiotherapy
Secondary outcomes:
measure: Progress-Free Survival (PFS)
timeFrame: 3 years after Radiotherapy
measure: Pregnancy and birth outcome
timeFrame: Within 6 month of diagnosis, or 3-5years after Radiotherapy
measure: Overall Survival (OS)
timeFrame: 3 years after Radiotherapy
measure: Locoregional Relapse-Free Survival (LRFS)
timeFrame: 3 years after Radiotherapy
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: 3 years after Radiotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: