Anal Cancer, Chemoradiation, Quality of Life
Conditions
Keywords
anal cancer, quality of life, chemoradiation
Brief summary
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
Detailed description
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.
Interventions
OTHEREORTC QLQ C30
standardized questionaire
OTHEREORTC QLQ CR29
standardized questionaire
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically proven anal cancer without distant metastases * indication for definitive chemoradiation therapy based on multidisciplinary evaluation * age \>=18 years * written informed consent * ability to answer the standardized questionaires according to the treating physician
Exclusion criteria
* age \< 18 years * prior systemic therapy with regard to anal cancer * distant metastases * second malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qol (EORTC QLQC30) absolute values and change over time | day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 | Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time |
| Qol (EORTC QLQCR29) absolute values and change over time | day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 | Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| freedom from treatment failure | end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 | absence of disease progression inside or outside the target volume of radiation therapy |
| overall survival | end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 | absence of death from any cause |
| local control | end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 | absence of disease progression inside the target volume of radiation therapy |
| late toxicity | end of week 32, 58, 84, 110, 162, 214, 266 | late toxicity caused by chemoradiation according to CTCAE 4.03 |
| acute toxicity | day 0, end of week 6, 12, 19 | acute toxicity caused by chemoradiation according to CTCAE 4.03 |
| distant control | end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266 | absence of disease progression outside the target volume of radiation therapy |
Countries
Germany
Contacts
Primary ContactFalk Roeder, MD
Backup ContactSabine Gerum, MD
Outcome results
None listed