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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard delineation | Active Comparator | The medial edge of the level III-IVa lymphatic drainage areas was the medial edge to encompass the common carotid artery. And the anterior boundary of the level III-IVa drainage area as the anterior edge of the common carotid artery or posterior edge of the thyrohyoid muscle rather than the anterior edge of the sternocleidomastoid muscle or the posterior third of the thyrohyoid muscle, to reduce thyroid radiation exposure |
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| Modified delineation | Experimental | The medial edge of the level III-IVa lymphatic drainage areas was redefined to the lateral edge of the common carotid artery, sparing the common carotid artery area. The anterior boundary of the level III-IVa drainage area as the anterior edge of the common carotid artery or posterior edge of the thyrohyoid muscle, rather than the anterior edge of the sternocleidomastoid muscle or the posterior third of the thyrohyoid muscle, to reduce thyroid radiation exposure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified delineation | Radiation | Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV) |
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| Measure | Description | Time Frame |
|---|---|---|
| Regional Recurrence-free Survival | Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death from any cause or the last follow-up date. | 3 years |
| Disease-free Survival |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochang Gong, MD | Contact | 8613970020755 | gxcanddw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D013959 | Thyroid Diseases |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Standard delineation | Radiation | Standard delineation |
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Disease-Free Survival (DFS) is defined as the time interval from the date of randomization to the date of tumor recurrence or death from any cause.
| 3 years |
| Hypothyroidism-Free Survival | Hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of hypothyroidism or the last follow-up date. | 3 years |
| Clinical Hypothyroidism-Free Survival | Clinical hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of clinical hypothyroidism or the last follow-up date. | 3 years |
| Global Health Status | The quality of life of patients in the two groups will be assessed using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). | 1year, 2 year and 3 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D004700 | Endocrine System Diseases |
| D014947 | Wounds and Injuries |