Clinical trial NCT06752239: Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Quality of Life
Thyroid Diseases
Radiotherapy Side Effect
Radiotherapy
Keywords: Nasopharyngeal Carcinoma
Quality of Life
Thyroid Function Protection
Radiotherapy
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Regional Recurrence-free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Disease-free Survival
timeFrame: 3 years
measure: Hypothyroidism-Free Survival
timeFrame: 3 years
measure: Clinical Hypothyroidism-Free Survival
timeFrame: 3 years
measure: Global Health Status
timeFrame: 1year, 2 year and 3 years
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
Study officials:
References: