Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Quality of Life; Thyroid Diseases; Radiotherapy Side Effect; Radiotherapy

• Registration Number: NCT06752239
• Lead Sponsor: Jiangxi Provincial Cancer Hospital

Brief Summary

This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-27
• Study First Posted: 2024-12-30
• Study Start: 2025-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

1. Male or female, aged 18-70 years; 2. Pathologically confirmed nasopharyngeal carcinoma; 3. No positive lymph nodes in unilateral or bilateral regions III and IVa; 4. Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis; 5. Normal thyroid function; 6. ECOG performance status of 0-1; 7. Treatment-naïve patients who have not received any prior antitumor therapy; 6. No contraindications to radiotherapy or chemotherapy; 9. Adequate organ function, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); Biochemical criteria: ALT and AST < 1.5 × ULN, ALP < 2.5 × ULN, total bilirubin < ULN, BUN and creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).

2. Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.

Exclusion Criteria

1. History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
2. History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
3. History of neck surgery;
4. Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5 × ULN), or psychiatric disorders;
5. History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
6. Other family or social factors, as judged by the investigator, may force the study's early termination, compromise patient safety, or affect the collection of trial data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Regional Recurrence-free Survival	3 years	Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 years	Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death from any cause or the last follow-up date.
Disease-free Survival	3 years	Disease-Free Survival (DFS) is defined as the time interval from the date of randomization to the date of tumor recurrence or death from any cause.
Hypothyroidism-Free Survival	3 years	Hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of hypothyroidism or the last follow-up date.
Clinical Hypothyroidism-Free Survival	3 years	Clinical hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of clinical hypothyroidism or the last follow-up date.
Global Health Status	1year, 2 year and 3 years	The quality of life of patients in the two groups will be assessed using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30).

Trial Locations

Locations (1)

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China