Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

NCT ID: NCT06752239

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2031-12-31

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.

Conditions

Nasopharyngeal Carcinoma; Quality of Life; Thyroid Diseases; Radiotherapy Side Effect; Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard delineation

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

Group Type: ACTIVE_COMPARATOR

Standard delineation

Intervention Type: RADIATION

Standard delineation

Modified delineation

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.

Group Type: EXPERIMENTAL

Modified delineation

Intervention Type: RADIATION

Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)

Interventions

Modified delineation

Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)

Intervention Type: RADIATION

Standard delineation

Standard delineation

Intervention Type: RADIATION

Other Intervention Names

MD

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jingao Li

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaochang Gong, MD

Role: CONTACT

gxcanddw@163.com

8613970020755

Facility Contacts

Jingao Li, PhD

Role: primary

ndzhlyy0005@ncu.edu

15270186250

Other Identifiers

PROTECT-NPC

Identifier Type: -

Identifier Source: org_study_id