Colorectal Cancer (CRC) Cetuximab Elderly Frail

Colorectal Cancer Metastatic Clinical Trial

Official title: 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).

Status Terminated

Clinical Trial Summary

OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil alone.

Clinical Trial Description

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 technique

• 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-ELD14 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

• NCT number: NCT01522612
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Terminated
• Phase: Phase 2
• Start date: April 2013
• Completion date: January 2015