Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

Phase 2

Completed

• Conditions: Colorectal Cancer; Non Resectable Metastasis; Reference Lesion; Biopsy; Thymidylate Synthase Quantitation
• Interventions: Drug: FUFA; Drug: systemic chemotherapy

• Registration Number: NCT01212718
• Lead Sponsor: University of Ulm

Brief 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.

Detailed 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 Timeline

• Study Start: 2001-07
• Primary Completion: 2010-06
• Status Verified: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-30
• Last Update Submitted: 2010-09-30
• Study First Posted: 2010-10-01
• Last Update Posted: 2010-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• patients (>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy
• a performance status WHO 0-2 (Karnofsky >= 60%)
• an estimated life expectancy of at least 3 months
• written informed consent

Exclusion Criteria

• patients older than 75 years not fulfilling these criteria
• brain metastases or a secondary cane
• a history of a systemic palliative chemotherapy
• and an adjuvant chemotherapy (within 6 months)
• pregnant or nursing women
• a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical
• laboratory and social conditions not allowing chemotherapy and follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-FU	FUFA	FUFA 5-flurouracil and folinic acid control
Folfiri	systemic chemotherapy	5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm

Primary Outcome Measures

Name	Time	Method
Best response to first-line chemotherapy (recist)	1 year	Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).

Secondary Outcome Measures

Name	Time	Method
overall survival, toxicity, treatment related complications, time to progression	3-year	See above.

Trial Locations

Locations (1)

Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm; 🇩🇪 Ulm, Germany