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

Quality of Life Clinical Trial

— LANACARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792854
• Other study ID #: V1 10/2018
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: December 2026

Study information

• Verified date: January 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: Falk Roeder, MD
• Phone: +49894400
• Email: falk.roeder[@]t-online.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Chemoradiation
• Quality of Life

Intervention

Other:
• EORTC QLQ C30
standardized questionaire
• EORTC QLQ CR29
standardized questionaire

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, University Hospital, LMU Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	overall survival	absence of death from any cause	end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Secondary	acute toxicity	acute toxicity caused by chemoradiation according to CTCAE 4.03	day 0, end of week 6, 12, 19
Secondary	late toxicity	late toxicity caused by chemoradiation according to CTCAE 4.03	end of week 32, 58, 84, 110, 162, 214, 266