Optimizing radiotherapy to protect thyroid function in nasopharyngeal carcinoma patients

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

This study is testing whether a new way of giving radiotherapy can better protect the thyroid gland in patients with nasopharyngeal cancer compared to the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Jiangxi Provincial Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT06752239 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, randomized controlled Phase III clinical trial compares the efficacy of modified delineation radiotherapy against standard delineation radiotherapy in patients with nasopharyngeal carcinoma. The focus is on prophylactic irradiation of neck lymphatic drainage areas III/IVa, assessing the incidence of primary hypothyroidism, quality of life, and adverse events between the two treatment groups. The study aims to determine if the modified approach can better protect thyroid function while treating cancer.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve adults aged 18-70 with pathologically confirmed nasopharyngeal carcinoma and normal thyroid function.

Not a fit: Patients with prior antitumor therapy or those with contraindications to radiotherapy or chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved thyroid function preservation in patients undergoing treatment for nasopharyngeal carcinoma.

How similar studies have performed: Other studies have explored similar radiotherapy optimization approaches, indicating potential for success in enhancing patient outcomes.

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.

Where this trial is running

Nanchang, Jiangxi

• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Xiaochang Gong, MD

Conditions Nasopharyngeal Carcinoma; Quality of Life; Thyroid Diseases; Radiotherapy Side Effect; Radiotherapy; Thyroid Function Protection