Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
1 other identifier
interventional
474
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2023
Longer than P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedStudy Start
First participant enrolled
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
ExpectedJanuary 28, 2025
January 1, 2025
1.7 years
March 8, 2023
January 25, 2025
Conditions
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
- +2 more secondary outcomes
Study Arms (2)
Reduced CTVn2
EXPERIMENTALPatients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
Conventional CTVn2
ACTIVE COMPARATORPatients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
Interventions
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).
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Jiangxi Provincial Cancer Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
- Chongqing University Cancer Hospitalcollaborator
- Dongguan People's Hospitalcollaborator
- LiuZhou People's Hospitalcollaborator
Study Sites (7)
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Dongguan People Hospital
Dongguan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Jiangxi Cancer Hospital of Nanchang University
Nanchang, Jiangxi, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chong Zhao, MD PhD
Sun Yat-sen University
Central Study Contacts
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
May 1, 2025
Study Completion (Estimated)
May 1, 2028
Last Updated
January 28, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share