Clinical trial NCT03792854: Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
Official title: Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Cancer
Quality of Life
Chemoradiation
Keywords: anal cancer
quality of life
chemoradiation
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: see eligibility criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Qol (EORTC QLQC30) absolute values and change over time
timeFrame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
measure: Qol (EORTC QLQCR29) absolute values and change over time
timeFrame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Secondary outcomes:
measure: local control
timeFrame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
measure: distant control
timeFrame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
measure: freedom from treatment failure
timeFrame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
measure: overall survival
timeFrame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
measure: acute toxicity
timeFrame: day 0, end of week 6, 12, 19
measure: late toxicity
timeFrame: end of week 32, 58, 84, 110, 162, 214, 266
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Radiation Oncology, University Hospital, LMU Munich
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians Universität München
name: Falk Roeder, MD
role: PRINCIPAL_INVESTIGATOR
References: