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NCT Number: NCT03792854

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

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Chemoradiation Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Bavaria, 81377, Germany

Location status: Recruiting

Location contact

Falk Roeder, MD

CONTACT

[email protected]

+49894400 ext. 73729

Franziska Walter, MD

SUB_INVESTIGATOR

Michael Hoffmann, MD

SUB_INVESTIGATOR

Sabine Gerum, MD

CONTACT

[email protected]

+49894400 ext. 73729

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EORTC QLQ C30

Other

standardized questionaire

EORTC QLQ CR29

Other

standardized questionaire

Primary outcomes

  1. Qol (EORTC QLQC30) absolute values and change over time

    Time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266

    Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time

  2. Qol (EORTC QLQCR29) absolute values and change over time

    Time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266

    Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time

Secondary outcomes

  1. local control

    Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266

    absence of disease progression inside the target volume of radiation therapy

  2. distant control

    Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266

    absence of disease progression outside the target volume of radiation therapy

  3. freedom from treatment failure

    Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266

    absence of disease progression inside or outside the target volume of radiation therapy

  4. overall survival

    Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266

    absence of death from any cause

  5. acute toxicity

    Time frame: day 0, end of week 6, 12, 19

    acute toxicity caused by chemoradiation according to CTCAE 4.03

  6. late toxicity

    Time frame: end of week 32, 58, 84, 110, 162, 214, 266

    late toxicity caused by chemoradiation according to CTCAE 4.03

Study contacts

Contact information is provided by the study sponsor or research team.

Falk Roeder, MD

CONTACT

[email protected]

+49894400 ext. 73729

Sabine Gerum, MD

CONTACT

[email protected]

+49894400 ext. 73729

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Acronym: LANACARE

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Jan 3, 2019
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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