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Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer

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

About this trial

Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant metastases (except supraclavicular nodes)

indication for neoadjuvant or definitive chemoradiation using either cisplatin/5-FU or carboplatin/paclitaxel with curative intent

age >= 18 years

written informed consent

Disqualifiers

age < 18 years

Treatment with palliative intent

distant metastases (except supraclavicular nodes)

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 OES-18

    Other intervention

    standardized questionaire

  • EORTC OG-25

    Other intervention

    standardized questionaire

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: neoadjuvant chemoradiation3 interventions
Group B: definitive chemoradiation3 interventions

Trial outcomes

Primary outcomes

1

Quality of life

Quality of life measured by standardized EORTC questionaires

Time frame
planning CT (day 0), week 4 of RT, 6 weeks after end of RT, 3 months after end of RT, 6 months after end of RT, 12 months after end of RT, 24, 36, 48, and 60 months after end of RT

Secondary outcomes

1

Local control

Absence of local progression

Time frame
3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT
2

Distant Control

Absence of distant metastases

Time frame
3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT
3

freedom from treatment failure

Absence of local and distant failure

Time frame
3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT
4

Overall survival

Absence of death by any cause

Time frame
3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig-Maximilians - University of Munich

Lead sponsor

Source ClinicalTrials.gov
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