Metastatic patterns of level II-V cervical lymph nodes assessed per vertebral levels in nasopharyngeal carcinoma.
Guang-Li Zhu, Xiao-Min Zhang, Kai-Bin Yang...
https://pubmed.ncbi.nlm.nih.gov/36549338Actively Recruiting
Phase 3
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID07303023
Individualized Versus Standard Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma A Phase III Multicenter Randomized Controlled Trial
Led by Fudan University · Updated on 2025-12-24
462
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating individualized neck prophylactic irradiation for patients with nasopharyngeal carcinoma (NPC), focusing on tailoring radiation based on the extent and location of metastatic lymph nodes. This prospective, multicenter, phase III randomized controlled trial compares this individualized approach to standard upper neck prophylactic irradiation, aiming to confirm if the new method is feasible and not less effective. The study also examines survival outcomes, radiation-induced injuries, and quality of life, while considering advances in photon and carbon-ion radiotherapy techniques. Patients will be randomly assigned to one of two groups: the investigational arm where irradiation targets at least Level II of the upper neck and extends 3 cm below the lowest metastatic lymph node if present, and the control arm which receives standard bilateral upper neck irradiation covering up to Level III with additional lower neck irradiation if upper nodes are positive. Radiation doses vary by treatment type; photon IMRT alone or combined photon IMRT with carbon-ion therapy are used, with specified dosing schedules. Some patients may receive induction chemotherapy with gemcitabine and cisplatin, followed by concurrent cisplatin chemotherapy as appropriate. Participants will undergo tumor response evaluations using EBV-DNA levels and MRI scans at key treatment milestones and follow-ups every three months for the first two years. Quality of life questionnaires are completed before, during, and after treatment. The primary outcome is neck recurrence-free survival at three years, with secondary outcomes including overall survival and local recurrence-free survival. Safety monitoring and long-term follow-up are integral to assessing treatment effectiveness and impact on patients' quality of life over the course of the study.
CONDITIONS
Brief Title
Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC
Who Can Participate
Age: 18Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma
- Staged as T1-4N0-3 M0, Stage I-III per UICC/AJCC 9th edition
- No distant metastasis confirmed by imaging
- Ability to undergo MRI examination
- Adequate hematopoietic, liver, and renal function meeting radiotherapy requirements
- ECOG performance status 0-1 without severe comorbidities
- Life expectancy of at least 12 months
- Provided written informed consent
You will not qualify if you...
- Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma
- Presence of distant metastasis or skip metastases in cervical lymph nodes
- Pregnancy or lactation
- Unwillingness to provide informed consent
- Prior radiotherapy to head and neck region
- Contraindications to photon or carbon-ion therapy
- Inability to comply with follow-up visits
- Known allergies to study chemotherapeutic agents or imaging contrast
- Contraindication to contrast-enhanced MRI
- Major organ dysfunction or severe uncontrolled infection
- History of immunodeficiency or organ transplantation
- History of other malignancies except basal cell carcinoma
- History of substance or alcohol abuse
- Any condition posing risk for study discontinuation or data integrity issues
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 5 to 7 weeks depending on radiotherapy fractionation and chemotherapy cycles
Participants receive individualized or standard neck irradiation with photon IMRT alone or combined with carbon-ion radiotherapy. Some may also receive induction chemotherapy and concurrent chemotherapy as part of their treatment.
Daily visits for radiotherapy sessions and chemotherapy cycles over treatment period
Follow-up
Duration - Up to 3 years post-treatment
Participants are monitored after treatment completion with tumor response assessments including EBV-DNA levels and MRI scans, as well as quality of life questionnaires.
Visits every three months for the first two years, then as per protocol
Trial Site Locations
Total: 6 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
2
Eye, Ear, Nose and Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
4
Sichuan Cancer Hospital & Institute
Chengdu, China
Not Yet Recruiting
5
Chongqing Cancer Hospital
Chongqing, China
Not Yet Recruiting
6
Shanghai Proton and Heavy Ion Center
Shanghai, China
Actively Recruiting
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Research Team
X
Xiyin Guan, MD. PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Involved site radiation therapy in stage I-III nasopharyngeal carcinoma with limited lymph node burden (ISRT-NPC) or elective region irradiation: a study protocol for a multicenter non-inferiority randomized controlled phase III clinical trial.
Yang Liu, Yaqian Han, Feng Liu...
https://pubmed.ncbi.nlm.nih.gov/37537541Optimizing Cervical Target Volume in Patients with Nasopharyngeal Cancer Based On Nodal Drainage Distance.
Yang Liu, Wenbin Yan, Chaosu Hu...
https://pubmed.ncbi.nlm.nih.gov/38349999Distribution of regional lymph nodes metastasis in 870 cases of nasopharyngeal carcinoma and the suggestions for individualized elective prophylactic neck irradiation with intensity-modulated radiotherapy.
Lei Wang, Zheng Wu, Qian He...
https://pubmed.ncbi.nlm.nih.gov/38156901Individualized clinical target volume delineation and efficacy analysis in unilateral nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT): 10-year summary.
De-Huan Xie, Zheng Wu, Wang-Zhong Li...
https://pubmed.ncbi.nlm.nih.gov/35486182Characteristics of local extension based on tumor distribution in nasopharyngeal carcinoma and proposed clinical target volume delineation.
Zheng Wu, Bin Qi, Fei-Fei Lin...
https://pubmed.ncbi.nlm.nih.gov/36870606Reduced-volume radiotherapy versus conventional-volume radiotherapy after induction chemotherapy in nasopharyngeal carcinoma: An open-label, noninferiority, multicenter, randomized phase 3 trial.
Ling-Long Tang, Lin Chen, Gui-Qiong Xu...
https://pubmed.ncbi.nlm.nih.gov/39970442Reduced-Volume Irradiation of Uninvolved Neck in Patients With Nasopharyngeal Cancer: Updated Results From an Open-Label, Noninferiority, Multicenter, Randomized Phase III Trial.
Cheng-Long Huang, Ning Zhang, Wei Jiang...
https://pubmed.ncbi.nlm.nih.gov/38507662International Consensus Guideline on Delineation of the Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma (2024 Version).
Shao-Jun Lin, Qiao-Juan Guo, Qin Liu...
https://pubmed.ncbi.nlm.nih.gov/40419028Ninth Version of the AJCC and UICC Nasopharyngeal Cancer TNM Staging Classification.
Jian-Ji Pan, Hai-Qiang Mai, Wai Tong Ng...
https://pubmed.ncbi.nlm.nih.gov/39388190