Идёт набор NCT02333110

GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors

Без фазы С лечением Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation

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: spatially fractionated radiation therapy.
Кому может быть актуально: Состояния в реестре: Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation. 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: Канада
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

Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors

Обзор

Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. However, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated radiation (SFR) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. The present study is proposing to validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.

Вмешательства

Лучевая терапия spatially fractionated radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy

Первичные конечные точки

Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire [Срок оценки: 3 months post treatment]

Вторичные конечные точки (4)

Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0) [Срок оценки: 1 week]
Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0) [Срок оценки: 3, 6, 9, 12 months]
Cost-effectiveness, as measured by evaluating the cost of the procedure per patient and the efficacy of treatment with regards to symptom relief and tumor response [Срок оценки: 3 months]
Tumor response, measured on CT-scan [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Patient with histologically or cytologically confirmed malignancy. All malignant histologies/cytologies are eligible.
Patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. Melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation
Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis
WHO performance status of 0-2
Aged 18 years or older
Ability to sign and understand an informed consent form