Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

Study Overview
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Brief Summary
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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 definitive chemoradiation for anal cancer

Detailed Description
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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 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.

Official Title
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Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)

Conditions
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Anal Cancer, Quality of Life, Chemoradiation

Intervention / Treatment
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* Other: EORTC QLQ C30
* Other: EORTC QLQ CR29


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: EORTC QLQ C30|standardized questionaire|
|Other: EORTC QLQ CR29|standardized questionaire|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal cancer, quality of life, chemoradiation