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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EORTC QLQ C30 | Other | standardized questionaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| QoL (EORTC QLQC30) absolute values and change over time | Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time | 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 | Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| acute toxicity | acute toxicity by Radiation or chemoradiation according to CTCAE 4.03 | short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14 |
| late toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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see eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Falk Roeder, MD | Contact | +49 89 4400 | 73729 | Falk.Roeder@t-online.de |
| Sabine Gerum, MD | Contact | +49 89 4400 | 73770 | Sabine.Gerum@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Falk Roeder, MD | Ludwig-Maximilians Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, University Hospital, LMU Munich | Recruiting | Munich | Bavaria | 81377 | Germany |
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| EORTC QLQ CR29 | Other | standardized questionaire |
|
late toxicity according to CTCAE 4.03
| 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 | Absence of local regrowth | 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 | Absence of distant metastases | 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 | Absence of local or distant relapse | 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 | Absence of death from any cause | 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 |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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