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Selecting Treatment in Colorectal Cancer:Capecitabine or 5-fluorouracil Selection to be Combined With Oxaliplatin or Irinotecan as First-line Chemotherapy in Advanced Colorectal Cancer

NCT01071655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2015-03-24

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of the capecitabine or 5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal cancer

Conditions

Interventions

DRUG

BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX

BVZ + XELOX. Bevacizumab 7,5 mg/kg day 1; capecitabine 1000 mg/m2/12 h days 1-14; oxaliplatin 130 mg/m2 day 1 BVZ + XELIRI. Bevacizumab 7,5 mg/kg day 1; Capecitabine 800 mg/m2/12 h days 1-14; Irinotecan 200 mg/m2 day 1 BVZ + FUIRI. Bevacizumab 5 mg/kg biweekly; 5-FU 2.250 mg/m2 weekly; Irinotecan 80 mg/m2 weekly BVZ + FUOX. Bevacizumab 5 mg/kg biweekly; 5-FU 2.250 mg/m2 weekly; Oxaliplatin 85 mg/m2 biweekly

DRUG

BVZ+XELOX

BVZ + XELOX. Bevacizumab 7,5 mg/kg day 1; capecitabine 1000 mg/m2/12 h days 1-14; oxaliplatin 130 mg/m2 day 1

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Albert Abad · Institut Català d'Oncologia.Hospital Universitari Germans Trias i Pujol. Badalona. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01071655 on ClinicalTrials.gov