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Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase

NCT01212718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2010-10-01

No results posted yet for this study

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.

Conditions

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

Interventions

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)

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

Sponsors & Collaborators

  • Pfizer, Berlin Germany

    collaborator UNKNOWN

  • Medac, Hamburg, Germany

    collaborator UNKNOWN

  • Study Group Oncology of Gastrointestinal Tumors (FOGT)

    collaborator UNKNOWN

  • University of Ulm

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212718 on ClinicalTrials.gov