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van CCT (UK)


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van CCT (UK)


Phase II trial of combination therapy with oxaliplatin and capecitabine in patients with advanced esophageal cancer.


- candidate number1698
- NTR NumberNTR488
- ISRCTNISRCTN07447845
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsEMC 03-048 
- Public TitlePhase II trial of combination therapy with oxaliplatin and capecitabine in patients with advanced esophageal cancer.
- Scientific TitlePhase II trial of combination therapy with oxaliplatin and capecitabine in patients with advanced esophageal cancer.
- ACRONYMXelox
- hypothesisFor 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.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteriaMetastatic 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 criteriaPrior 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-apr-2003
- planned closingdate1-okt-2005
- Target number of participants43
- InterventionsOxaliplatin 130 mg/m2 IV day 1 and capecitabine 1000 mg/m2 twice daily orally days 1-14 (28 doses) repeated every 3 weeks.
- Primary outcome1. 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 outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A. Gaast, van der
- CONTACT for SCIENTIFIC QUERIESDr. A. Gaast, van der
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsBr J Cancer. 2007 May 7;96(9):1348-52. Epub 2007 Apr 17.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-sep-2005 - 11-sep-2008


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