Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Last updated: April 8, 2025
Sponsor: Jiangxi Provincial Cancer Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer Treatment

Carcinoma

Nasopharyngeal Cancer

Treatment

Modified delineation

Standard delineation

Clinical Study ID

NCT06752239
PROTECT-NPC
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, aged 18-70 years; 2. Pathologically confirmed nasopharyngealcarcinoma; 3. No positive lymph nodes in unilateral or bilateral regions III andIVa; 4. Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distantmetastasis; 5. Normal thyroid function; 6. ECOG performance status of 0-1; 7.Treatment-naïve patients who have not received any prior antitumor therapy; 6. Nocontraindications 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, orhematopoietic growth factors used within the past 7 days); Biochemical criteria: ALTand 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 theCockcroft-Gault formula).

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

Exclusion

Exclusion Criteria:

  1. History of other malignant tumors (excluding basal cell carcinoma/squamous cellcarcinoma of the skin or cervical carcinoma in situ);

  2. History of radiotherapy (excluding radiotherapy outside the planned target area forconditions such as melanoma);

  3. History of neck surgery;

  4. Any severe comorbidities that may pose risks to the study or affect compliance, suchas unstable heart disease requiring treatment, kidney disease, chronic hepatitis,poorly controlled diabetes (fasting blood glucose > 1.5 × ULN), or psychiatricdisorders;

  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'searly termination, compromise patient safety, or affect the collection of trialdata.

Study Design

Total Participants: 474
Treatment Group(s): 2
Primary Treatment: Modified delineation
Phase: 3
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2031

Connect with a study center

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.