Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase — FOGT5  

Colorectal Cancer Clinical Trial

Official title: Stratified and Randomized Multi-center Phase II - to Determine Potential Benefit of Treating Patients With Advanced Colorectal Cancer According to the Intratumoral TS RNA Levels

Status Completed

Clinical Trial Summary

The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU treatment in MCRC.

Clinical Trial Description

Eligible were patients with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.The biopsy was taken from the reference lesion either by surgery during primary tumor resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. Intratumoral relative TS mRNA expression levels were determined using samples shipped in RNA-preserving solution or as glass slides after microdissection of tumor cells. An independent company stratified the patients according to ther relative TS mRNA expression level in TS low and TS high followed by randomization to receive either FUFA of Folfiri. Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biopsy
• Colorectal Cancer
• Colorectal Neoplasms
• Non Resectable Metastasis
• Reference Lesion
• Thymidylate Synthase Quantitation

• NCT number: NCT01212718
• Study type: Interventional
• Source: University of Ulm
• Status: Completed
• Phase: Phase 2
• Start date: July 2001
• Completion date: September 2010