Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

Colorectal Cancer Clinical Trial

— FOGT5  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212718
• Other study ID #: FOGT5
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2010
• Last updated: September 30, 2010
• Start date: July 2001
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biopsy
• Colorectal Cancer
• Colorectal Neoplasms
• Non Resectable Metastasis
• Reference Lesion
• Thymidylate Synthase Quantitation

Intervention

Drug:
• FUFA
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)
• 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

Locations

Country	Name	City	State
Germany	Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm	Ulm

Sponsors (4)

Lead Sponsor	Collaborator
University of Ulm	Medac, Hamburg, Germany, Pfizer, Berlin Germany, Study Group Oncology of Gastrointestinal Tumors (FOGT)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year	No
Secondary	overall survival, toxicity, treatment related complications, time to progression	See above.	3-year	Yes

External Links

•   (homepage of institution)