Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer (NEOCARE)

Ludwig Maximilian University of Munich

Status: Enrolling

Conditions: Radiation Therapy; Quality of Life; Chemoradiation; Rectal Cancer

Treatments: Other: EORTC QLQ CR29; Other: EORTC QLQ C30

Study type: Observational

Funder types: Other

Identifiers

NCT03731130

V1 10.07.2018

Details and patient eligibility

About

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 neoadjuvant short term radiation or long-term chemoradiation followed by surgery

Full description

Observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course Irradiation or neoadjuvant Long-Course chemoradiation followed by surgery. QoL will be evaluated by standardized EORTC questionaires QLQ C30 and 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 Patient-assessed functional outcomes are planned.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically proven rectal Cancer without distant metastases
• indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary 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 rectal Cancer
• distant metastasis
• second malignancy

Trial design

100 participants in 2 patient groups

neoadjuvant short term radiation

Description:

Treatment with neoadjuvant short term radiation therapy (5x5 Gy) followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire.

Treatment:

Other: EORTC QLQ CR29

Other: EORTC QLQ C30

neoadjuvant long-term chemoradiation

Description:

Treatment with neoadjuvant Long-term chemoradiation followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire

Treatment:

Other: EORTC QLQ CR29

Other: EORTC QLQ C30