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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Fifth Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Fifth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Zhuhai
Contact Information
Primary
Ming-Yuan Chen, MD,PhD
chmingy@email.sysu.edu.cn
+8613903052650
Backup
You-Ping Liu, PhD
liuyp78@email.sysu.edu.cn
+8613751763276
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 86
Treatments
Experimental: Surgery plus low dose radiotherapy
Surgery:~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.
Experimental: Surgery
Endoscopic 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.
Related Therapeutic Areas
Sponsors
Collaborators: Nanfang Hospital, Southern Medical University, Fifth Affiliated Hospital of Guangzhou Medical University, Sun Yat-sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Huazhong University of Science and Technology Union Hospital (Nanshan Hospital), First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
Leads: Ming-Yuan Chen

This content was sourced from clinicaltrials.gov