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

Ludwig Maximilian University of Munich

Status: Enrolling

Conditions: Esophageal Cancer; Quality of Life; Chemoradiation

Treatments: Other: EORTC QLQ C30; Other: EORTC OG-25; Other: EORTC QLQ OES-18

Study type: Observational

Funder types: Other

Identifiers

NCT03712774

V1 08_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

neoadjuvant chemoradiation

Description:

Patient with esophageal Cancer treated by neoadjuvant chemoradiation followed by surgery will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

Treatment:

Other: EORTC OG-25

Other: EORTC QLQ OES-18

Other: EORTC QLQ C30

definitive chemoradiation

Description:

Patient with esophageal Cancer treated by definitive chemoradiation will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

Treatment:

Other: EORTC OG-25

Other: EORTC QLQ OES-18

Other: EORTC QLQ C30