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Идёт набор NCT07402525

Postoperative Radiotherapy for Early-stage Oral Tongue Squamous Cell Carcinoma Patients With Risk Factors: a Prospective, Multicenter, Randomized Controlled, Open-labelled Trial

Без фазы С лечением Oral Tongue Squamous Cell Carcinoma

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: Postoperative radiotherapy.
Кому может быть актуально
Состояния в реестре: Oral Tongue Squamous Cell Carcinoma. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to learn whether postoperative radiotherapy can delay disease recurrence in patients with early-stage oral squamous cell carcinoma who have high-risk factors. The main question it aims to answer is: Is the clinical outcome of early-stage tongue squamous cell carcinoma patients with risk factors after tumor enlargement resection receiving postoperative radiotherapy better than that of patients with simple follow-up observation? How is the safety? Researchers will compare the postoperative radiotherapy group and the simple follow-up observation group to see if there are differences between the two groups in terms of 3-year disease-free survival rate, 5-year disease-free survival rate, overall survival rate, toxicity events, and quality of life. Participants of postoperative radiotherapy group will receive postoperative radiotherapy 6-8 weeks after surgery.

Вмешательства

  • Лучевая терапия Postoperative radiotherapy
    Radiation therapy should commence immediately after the surgical wound has fully healed, typically 4 to 6 weeks post-operation, but no later than 8 weeks post-operation

Первичные конечные точки

  • 3-year DFS [Срок оценки: 3 years]
Вторичные конечные точки (5)
  • 5-year OS [Срок оценки: 5 years]
  • 5-year DFS [Срок оценки: 5 years]
  • acute toxicity events [Срок оценки: 6 months]
  • Long-term toxicity events [Срок оценки: from 6 months after treatment to 5 years after treatment]
  • scores of Quality of life [Срок оценки: From enrollment to 5 years]

Критерии участия

Критерии включения

  • Age ≥ 18 years old and ≤ 70 years old, gender not limited;
  • Newly treated patients (who have not undergone radiotherapy, chemotherapy, or targeted therapy before);
  • Complete resection of the tumor with naked eye and no residual tumor observed in postoperative pathology;
  • The lesion is limited to the anterior 2/3 of the tongue (active part of the tongue);
  • Postoperative pathological diagnosis was squamous cell carcinoma of the tongue;
  • According to AJCC 8th edition, the pathological TNM staging is T1-2N0M0;
  • Having at least one risk factor: vascular cancer thrombus, nerve invasion, moderate or low differentiation;
  • The general status score of the Eastern Cancer Collaboration Group (ECOG) is 0-2 points;
  • Not participating in other clinical trials within the previous 4 weeks prior to screening; If other trials fail to screen cases, but meet the requirements of this trial, they can be enrolled.

Критерии исключения

  • Patients who invade the oropharynx, mouth floor, cheeks, neck, and other organs;
  • Have received chemotherapy or other anti-tumor drugs;
  • Previously received radiation therapy for the head and neck area;
  • Patients with active autoimmune diseases that require systemic treatment in the past;
  • Pregnant or lactating women;
  • Individuals with acute infections that are difficult to control;
  • Patients with drug abuse, drug abuse, long-term alcoholism and AIDS;
  • The subjects also have other known invasive malignant tumors (excluding those with no evidence of tumor recurrence through treatment and a duration of more than 2 years);
  • Researchers believe that there are other conditions that hinder patients from participating in this trial.

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 · 28 центров
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Cancer Hospital Chinese Academy of Medical Sciences — Chaoyang
  • Fujian Cancer Hospital — Фучжоу
  • Cancer prevention and treatment center, sun yat-sen university — Guandong
  • Harbin Medical University Cancer Hospital — Харбин
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
  • Renmin Hospital of Wuhan University — Ухань
  • Hunan Provincial People's Hospital — Чанша
  • … и ещё 20 центров

Идентификаторы

NCT: NCT07402525 · 2025-0846

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗