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

Not Applicable

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Surgery; Intensity Modulated Radiotherapy
• Interventions: Procedure: Endoscopic nasopharyngectomy followed close follow-up; Radiation: Intensity-modulated Radiotherapy

• Registration Number: NCT06533267
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study Start: 2024-03-25
• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2034-03-25
• Study Completion: 2034-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 442

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery plus close follow-up	Endoscopic nasopharyngectomy followed close follow-up	Surgery: Endoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy.
Intensity modulated radiotherapy	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Fifth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Zhuhai, Guangdong, China