NCT06752239RecruitingPhase 3
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC
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
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 474 (estimated)
- First submitted
- 21 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Diseases
- Thyroid cancer
- NCT number
- NCT06752239
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 474
- From 1 Jan 2025 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
Lab values
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangxi Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.