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

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Brief Title

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)

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.
    


Study Type

Observational


Primary Outcome

Qol (EORTC QLQC30) absolute values and change over time

Secondary Outcome

 local control

Condition

Anal Cancer

Intervention

EORTC QLQ C30


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

December 1, 2018

Completion Date

December 2026

Primary Completion Date

December 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Falk Roeder, MD, +49894400, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03792854

Organization ID

V1 10/2018


Responsible Party

Principal Investigator

Study Sponsor

Ludwig-Maximilians - University of Munich


Study Sponsor

Falk Roeder, MD, Principal Investigator, Ludwig-Maximilians Universität München


Verification Date

January 2019