Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

Association Européenne de Recherche en Oncologie

Status and phase: Unknown; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: Xeloda; Procedure: Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00189683

AERO-MC04

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)