Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00189683
• Other study ID #: AERO-MC04
• Status: Recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005

Study information

• Verified date: September 2005
• Source: Association Européenne de Recherche en Oncologie
• Contact: Annie Jouhaud
• Phone: + 33 1 43 77 72 10
• Email: annie.jouhaud[@]aero-eu.org
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Monitoring

• Xeloda

Locations

Country	Name	City	State
France	AERO	Creteil

Sponsors (2)

Lead Sponsor	Collaborator
Association Européenne de Recherche en Oncologie	Roche Pharma AG

Country where clinical trial is conducted

France,