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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Surgery; Radiotherapy
• Intervention / Treatment: Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy; Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection

Detailed Description

At present, the newly diagnosed non metastatic nasopharyngeal carcinoma has achieved good therapeutic effect under the treatment scheme of intensity modulated radiotherapy. The 5-year survival rate of the newly diagnosed stage Ⅰ nasopharyngeal carcinoma was more than 95%. But at the same time, all patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury, which will affect the quality of life of patients to varying degrees. For stage Ⅰ nasopharyngeal carcinoma with the primary lesion confined to the nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without preventive treatment of cervical lymph nodes.

Our previous research results showed that endoscopic surgery could achieved similar survival outcomes but less adverse events than radiotherapy for Stage Ⅰ nasopharyngeal carcinoma with short diameter of retropharyngeal lymph nodes<0.4cm or short diameter of cervical lymph nodes<0.6 and negative PET/CT findings. However, if there is the same results for all stage I NPC patients is still unclear. Therefore, this study aims to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection combined with low-dose radiotherapy or bilateral upper neck lymph node dissection compared with conventional intensity-modulated radiotherapy.

When the patients participated in this study, the stage ⅠNPC patient of experimental group 1 received endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection and low-dose radiotherapy. Low dose radiotherapy target area: CTV1 (tumor bed area); For the primary lesion with negative margin but less than 3mm, the margin area should be included; For patients with extracapsular invasion of lymph nodes, the extracapsular invasion 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. The prescription dose of intensity modulated radiotherapy: CTV1:36.00gy/15fr/2.40gy; CTV2:30.00gy/15fr/2.00gy. The patients in the stage Ⅰ in the experimental group 2 underwent endoscopic nasopharynx resection combined with retropharyngeal lymph node resection and bilateral upper neck lymph node dissection, without radiotherapy or chemotherapy after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming-Yuan Chen, MD,PhD; Phone Number: +8613903052650; Email: chmingy@email.sysu.edu.cn
• Study Contact Backup: Name: You-Ping Liu, PhD; Phone Number: +8613751763276; Email: liuyp78@email.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 516000
      • Recruiting
      • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Contact: Mingyuan Chen, PhD.; Phone Number: +8613903052650; Email: chmingy@mail.sysu.edu.cn
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Youping Liu, PhD.; Phone Number: +8613751763276; Email: liuyp78@email.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy; in experimental arm 1
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.	Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy; in experimental arm 1; Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection; in experimental arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.	2 years
Distant Metastasis-Free Survival (DMFS)	The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.	2 years
The incidence of serious complications	Common Adverse Event Evaluation Criteria (CTCAE) version 5.0 evaluates acute and late-stage subjective toxicity reactions.	2 years
Progression-Free Survival (PFS)	The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up.	2 years
Score of QLQ-C30	Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ-C30) before treatment, during treatment, after treatment and follow up.	2 years
Score of H&N 35	Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ-C30 and H&N 35) before treatment, during treatment, after treatment and follow up.	2 years
Incidence of acute postoperative complications	The incidence of acute postoperative complications.	2 weeks

Collaborators and Investigators

• Sponsor: Ming-Yuan Chen
• Collaborators: Sun Yat-sen University; First Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Zhongshan People's Hospital, Guangdong, China; Fifth Affiliated Hospital of Guangzhou Medical University; Huazhong University of Science and Technology Union Hospital (Nanshan Hospital); Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Ming-Yuan Chen, MD,PhD, Sun Yet-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma
• Other Study ID Numbers: SYSUCC-CMY-2024-02-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No