Clinical trial NCT03712774: Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
Official title: Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Chemoradiation
Esophageal Cancer
Keywords: quality of life
neoadjuvant
definitive
chemoradiation
esophageal cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: see eligibility criteria

Brief summary: 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.

Detailed description: Prospective observational study to evaluate the Quality of life based in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer. QoL will be evaluated by standardized EORTC questionaires. Acute and late toxicity will be assessed according to CTCAE 4.03. Outcome measures will include local Control, distant Control, freedom from Treatment failure and overall survival. Correlations are planned between Patient- and physician-assessed functional Outcome.

Eligibility criteria: Inclusion Criteria:

* 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
* ability to answer the standardized questionaires according to the treating physician

Exclusion Criteria:

* age \< 18 years
* Treatment with palliative intent
* distant metastases (except supraclavicular nodes)
* second malignancy
* Prior systemic treatment for esophageal Cancer
* Treatment in an interventional study

Primary outcomes:
measure: Quality of life
timeFrame: 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:
measure: Local control
timeFrame: 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
measure: Distant Control
timeFrame: 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
measure: freedom from treatment failure
timeFrame: 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
measure: Overall survival
timeFrame: 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
measure: acute toxicity
timeFrame: end of RT, 6 weeks after end of RT, 3 months after end of RT
measure: late toxicity
timeFrame: 6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Radiation Oncology, University Hospital, LMU Munich
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians Universität München
name: Falk Roeder, MD
role: PRINCIPAL_INVESTIGATOR
References: