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Recruiting NCT06752239

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Phase III Interventional Nasopharyngeal Carcinoma Quality of Life Thyroid Diseases Radiotherapy Side Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified delineation, Standard delineation.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma, Quality of Life, Thyroid Diseases, Radiotherapy Side Effect. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial

Overview

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.

Interventions

  • Radiation Modified delineation
    Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
  • Radiation Standard delineation
    Standard delineation

Primary outcome measures

  • Regional Recurrence-free Survival [Time frame: 3 years]
Secondary outcome measures (5)
  • Overall Survival [Time frame: 3 years]
  • Disease-free Survival [Time frame: 3 years]
  • Hypothyroidism-Free Survival [Time frame: 3 years]
  • Clinical Hypothyroidism-Free Survival [Time frame: 3 years]
  • Global Health Status [Time frame: 1year, 2 year and 3 years]

Eligibility criteria

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).

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

Exclusion criteria

  • History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
  • History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
  • History of neck surgery;
  • 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;
  • History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Jiangxi Cancer Hospital — Nanchang

Identifiers

NCT: NCT06752239 · PROTECT-NPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗