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

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Chemoradiation; Anal Cancer
• Intervention / Treatment: Other: EORTC QLQ C30; Other: EORTC QLQ CR29

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Falk Roeder, MD; Phone Number: 73729 +49894400; Email: falk.roeder@t-online.de
• Study Contact Backup: Name: Sabine Gerum, MD; Phone Number: 73729 +49894400; Email: sabine.gerum@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Department of Radiation Oncology, University Hospital, LMU Munich
      • Contact: Sabine Gerum, MD; Phone Number: 73729 +49894400; Email: sabine.gerum@med.uni-muenchen.de
      • Contact: Falk Roeder, MD; Phone Number: 73729 +49894400; Email: Falk.Roeder@med.uni-muenchen.de
      • Sub-Investigator: Franziska Walter, MD
      • Sub-Investigator: Michael Hoffmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

see eligibility criteria

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Falk Roeder, MD, Ludwig-Maximilians Universitat Munchen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; chemoradiation; anal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: V1 10/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No