Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase (FOGT5)
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.
Non Resectable Metastasis
Thymidylate Synthase Quantitation
Drug: systemic chemotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Best response to first-line chemotherapy (recist) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).
- overall survival, toxicity, treatment related complications, time to progression [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]See above.
|Study Start Date:||July 2001|
|Study Completion Date:||September 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 5-FU
FUFA 5-flurouracil and folinic acid control
2600/500 mg/m2 i.v. 24 h via port, 1 time weekly for six weeks, than have a break for 2 weeks (=8 weeks for 1 cycle)
Active Comparator: Folfiri
5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm
Drug: systemic chemotherapy
CPT-11, 80 mg/m2 for 90 minutes and 5 FU/FA 2000/500 mg/m2 iv. 24h via port; 1 time weekly for six weeks, than have a break for 2 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212718
|Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm|