RECRUITINGPhase 3INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1; 7. Treatment-naïve patients who have not received any prior antitumor therapy; 6. No contraindications to radiotherapy or chemotherapy; 9. your organs (liver, kidneys, etc.) are working well enough based on blood tests, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, white blood cell count (ANC) at least 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 willing to sign a consent form form, demonstrated good compliance, and agreed to follow-up.
Who Should NOT Join This Trial:
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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
RADIATION
Modified delineation
Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
RADIATION
Standard delineation
Standard delineation
Locations (1)
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China