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Идёт набор NCT03353467

Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Без фазы С лечением Nasopharyngeal Carcinoma Endoscopic Surgery Primary Napharyngeal Carcinama Stage I Nasopharyngeal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Endoscopic surgery, Intensity-modulated radiotherapy.
Кому может быть актуально
Состояния в реестре: Nasopharyngeal Carcinoma, Endoscopic Surgery, Primary Napharyngeal Carcinama, Stage I Nasopharyngeal Cancer. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Prospective Clinical Trial of Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Обзор

Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC. With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above. In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible. This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.

Вмешательства

  • Процедура Endoscopic surgery
    Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
  • Лучевая терапия Intensity-modulated radiotherapy
    All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.

Первичные конечные точки

  • overall survival [Срок оценки: 3 years]
Вторичные конечные точки (3)
  • distant metastasis-free survival [Срок оценки: 3 years]
  • loco-regional relapse-free survival [Срок оценки: 3 years]
  • the rates of complications [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Previously untreated, biopsy-proven World Health Organization (WHO) types II or III NPC; Stage I disease (American Joint Committee on Cancer 7th edition); Between 18 and 70 years old; Adequate bone marrow, liver and renal function; Satisfactory performance status: a score of 0 or 1 using the Eastern Cooperative Oncology Group System; Patients provided signed informed consent.

Критерии исключения

  • Evidence of relapse or distant metastasis; History of prior malignancy or previous treatment for NPC; The presence of uncontrolled life-threatening diseases; The investigator considered the patient unable to complete the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 5 центров
  • Sun Yat-sen University Cancer Center — Гуанчжоу
  • The First Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу
  • The First People's Hospital of Foshan — Гуанчжоу
  • Zhongshan People's Hospital — Zhongshan
  • The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning

Идентификаторы

NCT: NCT03353467 · 2017-FXY-055-NPC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗