Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01212718

Acronym

FOGT5

Enrollment

168

Registered

2010-10-01

Start date

2001-07-31

Completion date

2010-09-30

Last updated

2010-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biopsy, Colorectal Cancer, Non Resectable Metastasis, Reference Lesion, Thymidylate Synthase Quantitation

Keywords

Colorectal Cancer, non resectable metastasis, reference lesion, biopsy, thymidylate synthase quantitation

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.

Interventions

DRUGFUFA

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)

DRUGsystemic 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Best response to first-line chemotherapy (recist)	1 year	Response to chemotherapy was evaluated and documented according to the RECIST criteria after every therapy cycle (every two months).

Secondary

Measure	Time frame	Description
overall survival, toxicity, treatment related complications, time to progression	3-year	See above.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026