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Идёт набор NCT05943119

Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery

Фаза II С лечением Tumor, Solid

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 in painting dose on histoscannographic mapping, Standard pan-sinusal Radiotherapy.
Кому может быть актуально
Состояния в реестре: Tumor, Solid. Базовые параметры: от 18 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
Франция
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 patient is randomized to one of the following groups: * Experimental group: Radiotherapy in painting dose on histoscannographic mapping * Control group: standard pan-sinus radiotherapy

Вмешательства

  • Лучевая терапия Radiotherapy in painting dose on histoscannographic mapping
    The target volumes to be delineated are as follows: * High-risk CTV (Clinical Target Volume), corresponding to all initially invaded areas, as identified by comparison between the operative report and the anatomo-pathological report (ideally with histo-surgical mapping). * Low-risk CTV, corresponding to naso-sinusal structures not initially invaded but at risk of recurrence, and located close to the high-risk target volume, including at least 5 mm around the high-risk volume and excluding non-r
  • Лучевая терапия Standard pan-sinusal Radiotherapy
    The target volumes to be delineated are as follows: * High-risk CTV, including the entire post-operative cavity, * Low-risk CTV, adapted from the recommendations described by Lapeyre (Cancer/Radiotherapy 2005), and including at least 5 mm around the high-risk volume, excluding non-risk areas (muscle, bone).

Первичные конечные точки

  • Occurrence of radiation-induced nasal, ocular, auditory, endocrine and cerebral mucosal toxicities [Срок оценки: Toxicity grade ≥ 2 according to NCI-CTCAE V5.0 within 3 months of the end of IMRT.]
Вторичные конечные точки (9)
  • Tumor response [Срок оценки: measured at 6 months after radiotherapy]
  • Tumor response [Срок оценки: measured at 12 months after radiotherapy]
  • Tumor response [Срок оценки: measured at 18 months after radiotherapy]
  • Quality of life evaluation [Срок оценки: from the start of the study and up to 18 months after radiotherapy]
  • Description of acute and late clinical toxicities [Срок оценки: From the start of the study and up to 18 months after radiotherapy]
  • Dosimetry to healthy organs [Срок оценки: During radiotherapy]
  • Tissue changes [Срок оценки: from the start of the study and up to 18 months after radiotherapy]
  • Quality of life evaluation [Срок оценки: from the start of the study and up to 18 months after radiotherapy]
  • Quality of life evaluation [Срок оценки: from the start of the study and up to 18 months after radiotherapy]

Критерии участия

Критерии включения

  • Patients >18 years of age
  • Patient with a histologically confirmed malignant tumor of the sinuses, any histological type except melanoma, lymphoma, mesenchymal tumors (sarcoma)
  • Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy
  • Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)
  • Signature of informed consent prior to any specific study procedure
  • Subject affiliated to a social security system

Критерии исключения

  • Patient with not operated in place tumor
  • Patient with distant metastases
  • Patient treated with neoadjuvant chemotherapy
  • Pregnant or breast-feeding woman or absence of contraception during genital activity
  • History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years.
  • Simultaneous participation in another therapeutic clinical trial
  • Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent.
  • Patients unable to undergo trial monitoring for geographical, social or psychopathological 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

Франция · 3 центра
  • Centre Francois Baclesse — Caen
  • CHU CAEN — Caen
  • Centre Oscar Lambret — Lille

Идентификаторы

NCT: NCT05943119 · 2022-A02011-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗