Esophageal cancer.
Conditions
Interventions
Oxaliplatin 130 mg/m2 IV day 1 and capecitabine 1000 mg/m2 twice daily orally days 1-14 (28 doses) repeated every 3 weeks.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Metastatic or local-regional unresectable adenocarcinoma or squamous cell carcinoma esophagus or gastric junction, at least one unidimensional measurable lesion > 20mm (conventional), > 10mm (spiral), WHO 0-2, adequate hematological, renal and hepatic functions.
Exclusion criteria
Exclusion criteria: Prior treatment with oxaliplatin or capecitabine; prior (neo)adjuvant treatment for metastatic disease is allowed if completed at least 6 months prior to study start. malabsorption syndrome or inability to take oral medication, pre-existing motor or sensory neurotoxicity grade >1, active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy as measured by response rate and time to progression of the combination of oxaliplatin and capecitabine to patients with metastatic or local-regional unresectable carcinoma of the esophagus, esophagogatric junction and cardia; 2. To evaluate the safety of this combination therapy in such a group of patients; 3. To evaluate and assess quality of life during treatment. | — |
Contacts
Public ContactA. Gaast, van der
Erasmus Medical Center, Department of Medical Oncology, P.O. Box 2040,
Outcome results
None listed