Clinical trial NCT01212718: Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Non Resectable Metastasis
Reference Lesion
Biopsy
Thymidylate Synthase Quantitation
Keywords: Colorectal Cancer
non resectable metastasis
reference lesion
biopsy
thymidylate synthase quantitation
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Pfizer, Berlin Germany
name: Medac, Hamburg, Germany
name: Study Group Oncology of Gastrointestinal Tumors (FOGT)
First posted: 2010-10-01
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best response to first-line chemotherapy (recist)
timeFrame: 1 year
Secondary outcomes:
measure: overall survival, toxicity, treatment related complications, time to progression
timeFrame: 3-year
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm
Study officials:
References: