No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
N/A
Study objective
For patients with metastatic or local-regional unresectable esophageal carcinoma there is no alternative treatment.
In this trial it is studied whether combination chemotherapy with oxaliplatin and capecitabine prolongs survival and improves quality of life.
Study design
N/A
Intervention
Oxaliplatin 130 mg/m2 IV day 1 and capecitabine 1000 mg/m2 twice daily orally days 1-14 (28 doses) repeated every 3 weeks.
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL448 |
| NTR-old | NTR488 |
| Other | : EMC 03-048 |
| ISRCTN | ISRCTN07447845 |