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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLudwig-Maximilians - University of Munich

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically proven anal cancer without distant metastases

indication for definitive chemoradiation therapy based on multidisciplinary evaluation

age >=18 years

written informed consent

Disqualifiers

age < 18 years

prior systemic therapy with regard to anal cancer

distant metastases

second malignancy

Trial population

see eligibility criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EORTC QLQ C30

    Other intervention

    standardized questionaire

  • EORTC QLQ CR29

    Other intervention

    standardized questionaire

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
2

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

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

Secondary outcomes

1

local control

absence of disease progression inside the target volume of radiation therapy

Time frame
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
2

distant control

absence of disease progression outside the target volume of radiation therapy

Time frame
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
3

freedom from treatment failure

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

Time frame
end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
4

overall survival

absence of death from any cause

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

Other outcomes

Sponsors and contacts

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