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Идёт набор NCT06558981

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Фаза III С лечением Thyroid 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: Radiotherapy, radioiodine treatment.
Кому может быть актуально
Состояния в реестре: Thyroid Cancer. Базовые параметры: 14 лет — 80 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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Официальное название

The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer：a 1:1 Randomized Phase III Clinical Trial

Обзор

This study is a phase III randomized controlled clinical trial on the role of adjuvant radiotherapy in high-risk locally advanced differentiated thyroid cancer. Patients who meet the inclusion criteria were randomly assigned 1:1 to either the experimental group (adjuvant radiotherapy+RAI) or the control group (RAI), with LRFS as the primary endpoint of the study.

Вмешательства

  • Лучевая терапия Radiotherapy
    Ppatients would receive external radiation therapy within 6 weeks after surgery, using intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) techniques. RAI would be administered as standard care. The treatment window is within 6 months after surgery.
  • Другое radioiodine treatment
    RAI would be delivered based on the condition of residual lesions after surgery. The treatment window is within 6 months after surgery.

Первичные конечные точки

  • Local-regional Recurrence Free Survival （LRFS） [Срок оценки: 5 years after surgery]
Вторичные конечные точки (6)
  • Local-regional Recurrence Rate，LRR [Срок оценки: 5 years after surgery]
  • Progression Free Survival，PFS [Срок оценки: 5 years after surgery]
  • Overall Survival，OS [Срок оценки: 5 years after surgery]
  • Adverse Events，AE [Срок оценки: 5 years after surgery]
  • Quality of Life as assessed by QLQ-H&N35 [Срок оценки: 5 years after surgery]
  • Quality of Life as assessed by QLQ-C30 [Срок оценки: 5 years after surgery]

Критерии участия

Критерии включения

  • The patient voluntarily joined this study and signed an informed consent form;
  • Age: ≥ 14 years old,<80 years old, male or female not limited;
  • Histopathological diagnosis of differentiated thyroid cancer;
  • Surgical total or near total thyroidectomy;
  • The surgery did not achieve R0 resection, and R1/ R2 resection was performed. The volume of residual tumor in R2 resected patients is less than 2cm3;
  • The main organ functions are normal;
  • Good compliance and cooperation with follow-up.

Критерии исключения

  • Previously received radiation therapy for the head and neck area;
  • Differentiated thyroid cancer with poorly differentiated, or undifferentiated components;
  • There is distant metastasis;
  • Previously received 131I treatment;
  • Previously received or currently receiving targeted therapy, immunotherapy, chemotherapy;
  • Within 5 years or simultaneously suffering from other active malignant tumors. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group;
  • Pregnant or lactating women;
  • Other physical illnesses that affect patients' ability to receive standard treatment;
  • According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data;
  • Individuals with claustrophobia who are unable to undergo radiation therapy;
  • Patients deemed unsuitable for inclusion by other attending physicians.

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
  • Fudan Univeristy Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06558981 · ARAD-TC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗