Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Ulm
With
Pfizer, Berlin Germany
Medac, Hamburg, Germany
Study Group Oncology of Gastrointestinal Tumors (FOGT)
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
