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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Процедура 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.
• Лучевая терапия 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.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: 5 years]
• Incidence of ≥3 grade adverse events [Срок оценки: 5 years]

Вторичные конечные точки (7)

• Local Regional Relapse-Free Survival (LRRFS) [Срок оценки: 5 years]
• Distant Metastasis-Free Survival (DMFS) [Срок оценки: 5 years]
• Progress-Free Survival (PFS) [Срок оценки: 5 years]
• The proportion of patients with treatment related complications [Срок оценки: 5 years]
• Objective response rate (ORR) [Срок оценки: 3 months]
• Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [Срок оценки: 5 years]
• Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai

Идентификаторы

NCT: NCT06533267 · SYSUCC-CMY-2024-02-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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