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NCT Number: NCT06752239

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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.

Treatment and study plan

Modified delineation

Radiation

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

Other names: MD

Standard delineation

Radiation

Standard delineation

Primary outcomes

  1. Regional Recurrence-free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

  2. Disease-free Survival

    Time frame: 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.

  3. Hypothyroidism-Free Survival

    Time frame: 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.

  4. Clinical Hypothyroidism-Free Survival

    Time frame: 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.

  5. Global Health Status

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochang Gong, MD

CONTACT

[email protected]

8613970020755

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Registry information

Official study 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

Acronym: PROTECT-NPC

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Dec 30, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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