Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Radiotherapy; Complications
• Interventions: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

• Registration Number: NCT05780372
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-22
• Study Start: 2023-08-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

• Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
• All genders, range from 18-70 years old;
• ECOG score 0-1;
• Clinical stage I-IVa (AJCC/UICC 8th);
• Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
• No contraindications to chemotherapy or radiotherapy;
• Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Sign the consent form.

Exclusion Criteria

• Neck lymph nodes exist skipping metastasis;
• Distant metastases;
• Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
• Have or are suffering from other malignant tumors;
• Participating in other clinical trials;
• Pregnancy or lactation;
• Have uncontrolled cardiovascular disease;
• Severe complication, eg, uncontrolled hypertension;
• Mental disorder;
• Drug or alcohol addition;
• Do not have full capacity for civil acts.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced CTVn2	Chemotherapy	Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
Conventional CTVn2	Intensity Modulated Radiation Therapy	Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
Conventional CTVn2	Chemotherapy	Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
Reduced CTVn2	Intensity Modulated Radiation Therapy	Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.

Primary Outcome Measures

Name	Time	Method
Regional recurrence-free survival	3 years	From the date of randomization to regional recurrence or any death

Secondary Outcome Measures

Name	Time	Method
Progression free survival	3 years	From the date of randomization to local or regional recurrence, distant metastasis or any death
Acute toxicities	From the start of treatment until 3 months post treatment	Assessed with CTCAE v5.0
Late toxicities	3 years post treatment	Assessed with RTOG/EORTC
Overall survival	3 years	From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Local recurrence-free survival	3 years	From the date of randomization to local recurrence or any death
Distant metastasis-free survival	3 years	From the date of randomization to distant metastasis or any death
Quality of life score	During treatment and 3 years post treatment	Assessed with EORTC-Quality of life questionnaire-C30 version 3.0

Trial Locations

Locations (7)

Dongguan People Hospital; 🇨🇳 Dongguan, Guangdong, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Jiangxi Cancer Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Liuzhou Worker's Hospital; 🇨🇳 Liuzhou, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China