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…
ID
Bron
Verkorte titel
Aandoening
Esophageal cancer.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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; <br>
2. To evaluate the safety of this combination therapy in such a group of patients; <br>
3. To evaluate and assess quality of life during treatment.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Oxaliplatin 130 mg/m2 IV day 1 and capecitabine 1000 mg/m2 twice daily orally days 1-14 (28 doses) repeated every 3 weeks.
Publiek
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040,
A. Gaast, van der
Dr. Molewaterplein 40
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634897
a.vandergaast@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL448 |
| NTR-old | NTR488 |
| Ander register | : EMC 03-048 |
| ISRCTN | ISRCTN07447845 |