Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EORTC QLQ C30 | Other | standardized questionaire | ||
| EORTC QLQ CR29 | Other | standardized questionaire |
| Measure | Description | Time Frame |
|---|---|---|
| Qol (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 | 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 | day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 |
| Measure | Description | Time Frame |
|---|---|---|
| local control | absence of disease progression inside the target volume of radiation therapy | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
see eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Falk Roeder, MD | Contact | +49894400 | 73729 | falk.roeder@t-online.de |
| Sabine Gerum, MD | Contact | +49894400 | 73729 | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 |
| overall survival | absence of death from any cause | 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 | day 0, end of week 6, 12, 19 |
| late toxicity | late toxicity caused by chemoradiation according to CTCAE 4.03 | end of week 32, 58, 84, 110, 162, 214, 266 |
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| 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 |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided