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Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00189683
Enrollment
Unknown
Registered
2005-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2005-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

PROCEDUREMonitoring
PROCEDUREXeloda

Sponsors

Roche Pharma AG
CollaboratorINDUSTRY
Association Européenne de Recherche en Oncologie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

France

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026