NCT00189683

Brief Summary

To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 19, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Colorectal Cancer

Interventions

MonitoringPROCEDURE
XelodaPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
  • The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
  • Age\>18 years
  • ECOG status 0 to 2
  • Biological criteria prior to any chemotherapy:
  • Neutrophils\>1.5 109 g/l, platelets\>100 109/l, haemoglobin\>10 g/dl, Creatininaemia\<150 mol/l, bilirubinaemia\<2x normal level
  • Signed informed consent
  • Life expectancy \> 3 months

You may not qualify if:

  • Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
  • Tumour progression after first line chemotherapy or before randomization
  • Other tumour pathology
  • Symptomatic cerebral metastases
  • Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF\<50%) or coronary insufficiency)
  • Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine
  • Severe renal impairment (creatinine clearance \< 30 ml/min)
  • Severe psychiatric disorder (other than controlled depressive syndrome)
  • Patient participating in another experiment
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AERO

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Elizabeth Fabre-Guillevin, MD

    AERO

    PRINCIPAL INVESTIGATOR

  • Eric Van Cutsem, MD

    BGDO

    PRINCIPAL INVESTIGATOR

  • Marc Polus, MD

    BGDO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Jouhaud

CONTACT

+ 33 1 43 77 72 10annie.jouhaud@aero-eu.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Last Updated

September 19, 2005

Record last verified: 2005-09

Locations

FR(1)