locally advanced rectal cancer
Conditions
Brief summary
The primary endpoint is Net Benefit Treatment, according to the following hierarchical outcome measures: 1. Overall survival at 3 years after randomisation 2. Progression-free survival at 3 years after randomisation 3. Increased-grade peripheral sensory neuropathy at 3 years after randomisation 4. Grade ≥3 toxicities during treatment
Detailed description
Safety of study treatments defined as the frequency of adverse events reported according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., Quality of Life based on EORTC-QLQ-C30, EORTC-QLQ-C29, EORTC-QLQ-CIPN20 and EQ-5Q-5L questionnaires, Compliance to treatment, Pathological complete response, R0 resection, Organ preservation, Use of healthcare resources
Interventions
DRUGDEXAMETHASONE
DRUGCAPECITABINE
DRUGOXALIPLATIN
DRUGFLUOROURACIL
DRUGFOLINIC ACID
DRUGMETOCLOPRAMIDE
DRUGONDANSETRON
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety of study treatments defined as the frequency of adverse events reported according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., Quality of Life based on EORTC-QLQ-C30, EORTC-QLQ-C29, EORTC-QLQ-CIPN20 and EQ-5Q-5L questionnaires, Compliance to treatment, Pathological complete response, R0 resection, Organ preservation, Use of healthcare resources | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Net Benefit Treatment, according to the following hierarchical outcome measures: 1. Overall survival at 3 years after randomisation 2. Progression-free survival at 3 years after randomisation 3. Increased-grade peripheral sensory neuropathy at 3 years after randomisation 4. Grade ≥3 toxicities during treatment | — |
Countries
Belgium
Outcome results
None listed