Идёт набор NCT03731130

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

— Наблюдательное Rectal Cancer Quality of Life Radiation Therapy Chemoradiation

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: EORTC QLQ C30, EORTC QLQ CR29.
Кому может быть актуально: Состояния в реестре: Rectal Cancer, Quality of Life, Radiation Therapy, Chemoradiation. 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: Германия
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

Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Обзор

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery

Подробное описание

Observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course Irradiation or neoadjuvant Long-Course chemoradiation followed by surgery. QoL will be evaluated by standardized EORTC questionaires QLQ C30 and CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological Outcome will be assessed with regard to local and distant Control, Patterns of recurrence, freedom from Treatment failure and Overall survival. Correlations of physicians- and Patient-assessed functional outcomes are planned.

Вмешательства

Другое EORTC QLQ C30
standardized questionaire
Другое EORTC QLQ CR29
standardized questionaire

Первичные конечные точки

QoL (EORTC QLQC30) absolute values and change over time [Срок оценки: short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274]
QoL (EORTC QLQCR29) absolute values and change over time [Срок оценки: short-term radiation: day 0, end of week 1, week 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274]

Вторичные конечные точки (6)

acute toxicity [Срок оценки: short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14]
late toxicity [Срок оценки: short-term radiation: end of week 27, 53, 105, 157, 209, 261, long-term chemoradiation: end of week 27, 40, 66, 118, 170, 222, 274]
local control [Срок оценки: short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274]
distant control [Срок оценки: short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274]
freedom from Treatment failure [Срок оценки: short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274]
Overall survival [Срок оценки: short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274]

Критерии участия

Критерии включения

histologically proven rectal Cancer without distant metastases
indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary Evaluation
age >=18 years
written informed consent
ability to answer the standardized questionaires according to the treating physician