Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.

Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.

The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Surgery; Intensity Modulated Radiotherapy
• Intervention / Treatment: Procedure: Endoscopic nasopharyngectomy followed close follow-up; Radiation: Intensity-modulated Radiotherapy

Detailed Description

The newly diagnosed non-metastatic nasopharyngeal carcinoma has shown satisfactory therapeutic effect under the intensity modulated radiation. The 5-year survival rate of the newly diagnosed Ⅰ nasopharyngeal carcinoma was more than 95%. However, mos 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 primary lesion confined to nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without need of preventive treatment of cervical lymph nodes according to the prior study.

Based on our previous research results, we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 0.4cm and 0.6cm respectively, and the tumor diameter of nasopharyngeal primary tumor was ≤ 1.5cm. This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma.

In this study, the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor.

The patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up. The target area and dose of radiotherapy were as follows: GTVnx: primary lesion of the nasopharynx; CTV1: high-risk area and the entire nasopharynx; CTV2: low-risk area. The recommended intensity-modulated radiotherapy dose is GTVnx(69.96 Gy/33 Fr/2.12 Gy); CTV1(60.60 Gy/33 Fr/1.82 Gy); CTV2(54.12 Gy/33 Fr/1.64 Gy).

• Study Type: Interventional
• Enrollment (Estimated): 442
• 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: Youping Liu, PhD; Phone Number: +86137517763276; Email: liuyp78@email.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Youping Liu, MD; 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:

• Karnofsky score >70.
• Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically.
• According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I.
• The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative.
• Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria:

• MRI showed that the primary tumor diameter >1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation.
• 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 operation or radiotherapy.
• Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.

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 close follow-up; Surgery: Endoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy.	Procedure: Endoscopic nasopharyngectomy followed close follow-up; Radical resection of primary lesion using nasal endoscopy. After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.
Active Comparator: Intensity modulated radiotherapy; Radiotherapy: Intensity-modulated Radiotherapy: GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy	Radiation: Intensity-modulated Radiotherapy; GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy. After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as the time interval from randomization to death due to any cause.	5 years
Incidence of ≥3 grade adverse events	The proportion of patients with ≥3 grade adverse events according to CTCAE 5.0/RTOG criteria.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)	Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.	5 years
Local Regional Relapse-Free Survival (LRRFS)	Defined as the time from randomisation to the date of first locoregional relapse.	5 years
Distant Metastasis-Free Survival (DMFS)	Defined as the time interval from randomisation to the date of first distant metastases.	5 years
Progress-Free Survival (PFS)	Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.	5 years
The proportion of patients with treatment related complications	The proportion of patients with treatment related complications according to NCI-CTC5.0 criteria and RTOG criteria.	5 years
Objective response rate (ORR)	Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment. (according to tumor imaging examinations 3 months after the end of treatment/supplementary treatment)	3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)	Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.	5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: 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; Nanfang Hospital, Southern Medical University; Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital)
• Investigators: Principal Investigator: Ming-Yuan Chen, MD,PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 25, 2034
• Study Completion (Estimated): March 25, 2034

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: SYSUCC-CMY-2024-02-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No