NCT03731130

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

Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Rectal Cancer
• Quality of Life
• Radiation Therapy
• Chemoradiation

Interventions

Type	Name	Description
OTHER	EORTC QLQ C30	standardized questionaire
OTHER	EORTC QLQ CR29	standardized questionaire

Timeline

• Start date: 2018-10-05
• Primary completion: 2021-12-31
• Completion: 2026-12-31
• First posted: 2018-11-06
• Last updated: 2018-11-06

Locations

1 site across 1 country: Germany