Cetuximab for Elderly Patients With mCRC

Metastatic Colorectal Cancer Clinical Trial

Official title: Cetuximab Monotherapy and Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With KRAS- and BRAF Wild-type Metastatic Colorectal Cancer. A Multicenter Phase II Trial

Status Terminated

Clinical Trial Summary

OBJECTIVE: The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type and B-type Raf kinase (BRAF) wild-type metastatic colorectal cancer (mCRC).

Clinical Trial Description

Primary endpoint: If in a treatment arm the number of patients alive and without progression at 12 weeks is 17 or more, this arm will be considered promising, otherwise not promising. Additionally, a two-sided 95% confidence interval for the difference in Progression free survival (PFS) rates between the two arms will be calculated.

Secondary endpoints and patient characteristics:

• Laboratory values may be expressed as the absolute values (continuous variables) or/and as grading (ordinal categorical variables).

• Generally for each categorical variable the results will be summarized by frequencies and percentages. For response rates 95% Clopper-Pearson confidence intervals will be calculated.

• For each adverse event, the results will be summarized by frequencies and percentages of different grades among all cycles as well as by frequencies and percentages of the within-patient worst grades

• For each continuous variable the results will be summarized by descriptive statistics.

• Time-to-event variables will be presented by Kaplan-Meier curves and summarized by medians and 95% confidence intervals.

• All analysis will be done by treatment arm. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT01718808
• Study type: Interventional
• Source: Swiss Group for Clinical Cancer Research
• Status: Terminated
• Phase: Phase 2
• Start date: November 2012
• Completion date: January 2017