Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

NCT06752239 | Recruiting Phase 3 DMC

• 1 other identifier: PROTECT-NPC
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

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

Keywords

Nasopharyngeal Carcinoma; Quality of Life; Thyroid Function Protection; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Overall Survival

  3 years

• Disease-free Survival

  3 years

• Hypothyroidism-Free Survival

  3 years

• Clinical Hypothyroidism-Free Survival

  3 years

• Global Health Status

  1year, 2 year and 3 years

Study Arms (2)

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

Radiation: Standard delineation

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.

Radiation: Modified delineation

Interventions

Modified delineation RADIATION

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

Also known as: MD

Modified delineation

Standard delineation RADIATION

Standard delineation

Standard delineation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.

You may not qualify if:

• 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;
• 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;
• History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
• 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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Thyroid Diseases; Radiation Injuries

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Endocrine System Diseases; Wounds and Injuries

Central Study Contacts

Xiaochang Gong, MD

CONTACT

8613970020755; gxcanddw@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CN (1)