Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
- Conditions
- Anal CancerChemoradiationQuality of Life
- Registration Number
- NCT03792854
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- age < 18 years
- prior systemic therapy with regard to anal cancer
- distant metastases
- second malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
acute toxicity day 0, end of week 6, 12, 19 acute toxicity caused by chemoradiation according to CTCAE 4.03
late toxicity end of week 32, 58, 84, 110, 162, 214, 266 late toxicity caused by chemoradiation according to CTCAE 4.03
Trial Locations
- Locations (1)
Department of Radiation Oncology, University Hospital, LMU Munich
🇩🇪Munich, Bavaria, Germany