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Colorectal Cancer (CRC) Cetuximab Elderly Frail

NCT01522612 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-06-10

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

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

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Marc Peeters, MD, PhD · UNIVERSITAIR ZIEKENHUIS ANTWERPEN, Edegem, Belgium

  • Ulrich Wedding, MD · UNIVERSITAETSKLINIKUM JENA, Jena, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Belgium
  • Cyprus
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01522612 on ClinicalTrials.gov