NCT01522612

Colorectal Cancer (CRC) Cetuximab Elderly Frail

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Cetuximab	500 mg/m2 on day 1, Every 14 days Intravenously
DRUG	5-fluorouracil	Every 2 weeks, 400 mg/m2 on day 1; 2400 mg/m2 from day 1 to day 3, intravenously
DRUG	leucovorin	Every 2 weeks, Racemic leucovorin 200 mg/m2 or l-leucovorin 100 mg/m2 on day 1, intravenously

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-01-31
• Last updated: 2016-06-10

Locations

3 sites across 3 countries: Belgium, Cyprus, Spain