Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
LANACARE
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 3, 2019
January 1, 2019
3 years
January 2, 2019
January 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
local control
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
distant control
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
freedom from treatment failure
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
overall survival
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
acute toxicity
day 0, end of week 6, 12, 19
- +1 more secondary outcomes
Interventions
standardized questionaire
standardized questionaire
Eligibility Criteria
see eligibility criteria
You may qualify if:
- 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
You may not qualify if:
- age \< 18 years
- prior systemic therapy with regard to anal cancer
- distant metastases
- second malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiation Oncology, University Hospital, LMU Munich
Munich, Bavaria, 81377, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Falk Roeder, MD
Ludwig-Maximilians Universität München
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
January 2, 2019
First Posted
January 3, 2019
Study Start
December 1, 2018
Primary Completion
December 1, 2021
Study Completion (Estimated)
December 1, 2026
Last Updated
January 3, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share