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

Recruiting

• Conditions: Chemoradiation; Rectal Cancer; Quality of Life; Radiation Therapy
• Interventions: Other: EORTC QLQ C30; Other: EORTC QLQ CR29

• Registration Number: NCT03731130
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Study Timeline

• Study Start: 2018-10-05
• Study First Submitted: 2018-10-17
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-02
• Last Update Submitted: 2018-11-02
• Study First Posted: 2018-11-06
• Last Update Posted: 2018-11-06
• Primary Completion: 2021-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
neoadjuvant short term radiation	EORTC QLQ C30	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.
neoadjuvant long-term chemoradiation	EORTC QLQ CR29	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
neoadjuvant long-term chemoradiation	EORTC QLQ C30	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
neoadjuvant short term radiation	EORTC QLQ CR29	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.

Primary Outcome Measures

Name	Time	Method
QoL (EORTC QLQC30) absolute values and change over time	short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274	Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time
QoL (EORTC QLQCR29) absolute values and change over time	short-term radiation: day 0, end of week 1, week 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274	Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time

Secondary Outcome Measures

Name	Time	Method
distant control	short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274	Absence of distant metastases
local control	short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274	Absence of local regrowth
late toxicity	short-term radiation: end of week 27, 53, 105, 157, 209, 261, long-term chemoradiation: end of week 27, 40, 66, 118, 170, 222, 274	late toxicity according to CTCAE 4.03
acute toxicity	short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14	acute toxicity by Radiation or chemoradiation according to CTCAE 4.03
freedom from Treatment failure	short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274	Absence of local or distant relapse
Overall survival	short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274	Absence of death from any cause

Trial Locations

Locations (1)

Department of Radiation Oncology, University Hospital, LMU Munich; 🇩🇪 Munich, Bavaria, Germany