Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma
Endoscopic Nasopharyngectomy Combined with Retropharyngeal Lymph Node Dissection Plus Low-dose Radiotherapy Versus Bilateral Upper Neck Dissection for Newly Diagnosed Stage I Nasopharyngeal Carcinoma: a Randomized Controlled Clinical Trial
1 other identifier
interventional
86
1 country
2
Brief Summary
The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
November 14, 2024
July 1, 2024
5 years
July 25, 2024
November 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Local Regional Relapse-Free Survival (LRRFS)
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
2 years
Secondary Outcomes (7)
The incidence of serious complications
2 years
Overall Survival (OS)
2 years
Distant Metastasis-Free Survival (DMFS)
2 years
Progression-Free Survival (PFS)
2 years
Score of QLQ-C30
2 years
- +2 more secondary outcomes
Study Arms (2)
Surgery plus low dose radiotherapy
EXPERIMENTALSurgery: Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy. Radiotherapy: Low Dose Raiotherapy: Low dose radiotherapy target area: CTV1: tumor bed area; For cases where the margin of the primary lesion is negative but less than 3mm, the margin area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: Low risk infiltration area. Intensity modulated radiation therapy prescription dose: CTV1: 36.00Gy/15Fr/2.40Gy; CTV2: 30.00Gy/15Fr/2.00Gy.
Surgery
EXPERIMENTALEndoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy. Bilateral Upper Neck Lymph Node Dissection: the specific cleaning area is the lymph nodes upon the Hyoid bone regions.
Interventions
in experimental arm 1
in experimental arm 2
Eligibility Criteria
You may qualify if:
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I.
- Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
You may not qualify if:
- Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
- Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
- During pregnancy or lactation.
- Other patients that the chief physician considered as illegal for this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ming-Yuan Chenlead
- Fifth Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Fifth Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)collaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- First People's Hospital of Foshancollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
Study Sites (2)
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 516000, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Yuan Chen, MD,PhD
SUN yet-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professior,Chief physician
Study Record Dates
First Submitted
July 25, 2024
First Posted
November 14, 2024
Study Start
November 1, 2023
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
November 14, 2024
Record last verified: 2024-07