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 definitive chemoradiation for anal cancer
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 definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ 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 patients-assessed functional outcomes are planned.
Study Type
OBSERVATIONAL
Enrollment
100
standardized questionaire
standardized questionaire
Department of Radiation Oncology, University Hospital, LMU Munich
Munich, Bavaria, Germany
RECRUITINGQol (EORTC QLQC30) absolute values and change over time
Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time
Time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Qol (EORTC QLQCR29) absolute values and change over time
Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time
Time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
local control
absence of disease progression inside the target volume of radiation therapy
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
distant control
absence of disease progression outside the target volume of radiation therapy
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
freedom from treatment failure
absence of disease progression inside or outside the target volume of radiation therapy
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
overall survival
absence of death from any cause
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
acute toxicity
acute toxicity caused by chemoradiation according to CTCAE 4.03
Time frame: day 0, end of week 6, 12, 19
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late toxicity
late toxicity caused by chemoradiation according to CTCAE 4.03
Time frame: end of week 32, 58, 84, 110, 162, 214, 266