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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Best response to first-line chemotherapy (recist)
Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).
Germany: Federal Institute for Drugs and Medical Devices