Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06752239

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Led by Jiangxi Provincial Cancer Hospital · Updated on 2025-04-10

474

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 70 years
  • Pathologically confirmed nasopharyngeal carcinoma
  • No positive lymph nodes in unilateral or bilateral neck regions III and IVa
  • Clinical stage I to IVa without distant metastasis (AJCC/UICC 8th edition)
  • Normal thyroid function
  • ECOG performance status of 0 to 1
  • Treatment-nafve patients with no prior antitumor therapy
  • No contraindications to radiotherapy or chemotherapy
  • Adequate organ function meeting specified blood counts and biochemical criteria
  • Voluntarily agree to participate and comply with study follow-up
Not Eligible

You will not qualify if you...

  • History of other malignant tumors (except basal cell carcinoma/squamous cell carcinoma of skin or cervical carcinoma in situ)
  • History of radiotherapy (except outside planned target area for certain conditions)
  • History of neck surgery
  • Severe comorbidities affecting safety or compliance (unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders)
  • History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders
  • Family or social factors that may threaten safety, compliance, or data collection according to investigator judgment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China, 330029

Actively Recruiting

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Research Team

X

Xiaochang Gong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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