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Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

NCT ID: NCT01212718

Last Updated: 2010-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Non Resectable Metastasis Reference Lesion Biopsy Thymidylate Synthase Quantitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5-FU

FUFA 5-flurouracil and folinic acid control

Group Type ACTIVE_COMPARATOR

FUFA

Intervention Type DRUG

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)

Folfiri

5-fluouracil and folinic acid in combination with irinotecan (Folfiri) systemic chemotherapy intensified treatment arm

Group Type ACTIVE_COMPARATOR

systemic chemotherapy

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer, Berlin Germany

UNKNOWN

Sponsor Role collaborator

Medac, Hamburg, Germany

UNKNOWN

Sponsor Role collaborator

Study Group Oncology of Gastrointestinal Tumors (FOGT)

UNKNOWN

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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University of Ulm

Locations

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Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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FOGT5

Identifier Type: -

Identifier Source: org_study_id