Treatment of Patients With KRAS Wild Type Advanced Colorectal Cancer (CRC) With 5-Fluorouracil (5-FU) or 5- FU Plus an Epidermal Growth Factor Receptor (EGFR) Inhibitor (Cetuximab) Based on a Comprehensive Geriatric Assessment (CGA).
The primary efficacy analyses will be performed on the Intention-to-treat population.
The safety analyses will be performed on the Safety population.
- Median PFS and OS in each treatment arm with its 95% CI, estimated by the Kaplan-Meier
- Response rates by treatment arm with their exact 95% CI
- IADL sum score, G8 sum score and social situation by treatment arm at baseline and at
each timepoint of assessment
- QoL scores from the EORTC QLQ-C30 and QLQ-ELD15 modules by treatment arm at baseline
and at each timepoint of assessment
- Safety data by treatment arm in the Safety population. Worst toxicity grade over all
cycles according to the CTCAE criteria version 4.0 by treatment arm.
- Pharmaco-economics evaluation
Summary of proposed Phase II trial characteristics:
1. Total number of randomized patients: 150.
2. Total number of events at phase II analysis for primary endpoint: 110.
3. Total number of patients screened over the phase II: 250.
4. Total number of patients treated with cetuximab for the Phase II study: 75.
5. Maximum study duration: 19 months.
In the present study, HRQoL is an important secondary endpoint. The objective of the HRQoL
data collection in this Phase II trial is to assess the impact of the addition of cetuximab
on patients' HRQoL during treatment.
The hypothesis is that there will be no difference in patients' HRQoL between both treatment
arms during treatment. The HRQoL domains (from the EORTC QLQ-C30 module) which are expected
to be affected by treatment (to the same extent in both arms) are Global health status,
Fatigue, Pain and Stool habits.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Progression will be defined according to the "RECIST V1.1"
19 months from first patient in
Marc Peeters, MD, PhD
UNIVERSITAIR ZIEKENHUIS ANTWERPEN, Edegem, Belgium
Belgium: Federal Agency for Medicinal Products and Health Products