Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Carcinoma; Radiotherapy; Complications
• Intervention / Treatment: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 474
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Chongqing Cancer Hospital
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People Hospital
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
  • Guangxi
    • Liuzhou, Guangxi, China
      • Liuzhou Worker's Hospital
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Cancer Hospital of Nanchang University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced CTVn2; Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.	Radiation: Intensity Modulated Radiation Therapy; All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).; Other Names: IMRT; Drug: Chemotherapy; Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
Active Comparator: Conventional CTVn2; Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.	Radiation: Intensity Modulated Radiation Therapy; All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).; Other Names: IMRT; Drug: Chemotherapy; Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional recurrence-free survival	From the date of randomization to regional recurrence or any death	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Zhejiang Cancer Hospital; Wuzhou Red Cross Hospital; Chongqing University Cancer Hospital; Hubei Cancer Hospital; Jiangxi Provincial Cancer Hospital; First Hospital of China Medical University; Dongguan People's Hospital; The First Affiliated Hospital of Xiamen University; First Affiliated Hospital of Guangxi Medical University; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Liuzhou Workers' Hospital
• Investigators: Principal Investigator: Chong Zhao, MD PhD, Sun yat-sen University Cancer Center

Publications and helpful links

Helpful Links

• Home Page of Cancer Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Therapeutics; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Drug Therapy; Radiotherapy, Intensity-Modulated
• Other Study ID Numbers: Reduced CTV in NPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No