Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
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.
1. QoL (EORTC QLQC30) absolute values and change over time (Time Frame - 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): Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time
2. QoL (EORTC QLQCR29) absolute values and change over time (Time Frame - 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): Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time
Secondary outcome:
1. acute toxicity (Time Frame - short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14): acute toxicity by Radiation or chemoradiation according to CTCAE 4.03
2. late toxicity (Time Frame - 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): late toxicity according to CTCAE 4.03
3. local control (Time Frame - 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): Absence of local regrowth
4. distant control (Time Frame - 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): Absence of distant metastases
5. freedom from Treatment failure (Time Frame - 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): Absence of local or distant relapse
6. Overall survival (Time Frame - 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): Absence of death from any cause
neoadjuvant short term radiation Treatment with neoadjuvant short term radiation therapy (5x5 Gy) followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire.
neoadjuvant long-term chemoradiation Treatment with neoadjuvant Long-term chemoradiation followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire
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"Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer"
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