Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

NCT05780372 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: Reduced CTV in NPC
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 7

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.

Conditions

Nasopharyngeal Carcinoma; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• Regional recurrence-free survival

  From the date of randomization to regional recurrence or any death

  3 years

Secondary Outcomes (7)

• Overall survival

  3 years

• Local recurrence-free survival

  3 years

• Distant metastasis-free survival

  3 years

• Progression free survival

  3 years

• Acute toxicities

  From the start of treatment until 3 months post treatment

Study Arms (2)

Reduced CTVn2

EXPERIMENTAL

Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.

Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

Conventional CTVn2

ACTIVE COMPARATOR

Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.

Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

Interventions

Intensity Modulated Radiation Therapy RADIATION

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).

Also known as: IMRT

Conventional CTVn2; Reduced CTVn2

Chemotherapy DRUG

Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.

Conventional CTVn2; Reduced CTVn2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangxi Provincial Cancer Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Chongqing University Cancer Hospital: collaborator
• Dongguan People's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Liuzhou Workers' Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Wuzhou Red Cross Hospital: collaborator
• Hubei Cancer Hospital: collaborator
• First Hospital of China Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator

Study Sites (7)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Dongguan People Hospital

Dongguan, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Liuzhou Worker's Hospital

Liuzhou, Guangxi, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Jiangxi Cancer Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Related Links

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

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated; Drug Therapy

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Chong Zhao, MD PhD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

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: Doctor, Professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: August 8, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)