Condition category
Cancer
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
07/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A van der Gaast

ORCID ID

Contact details

Erasmus Medical Centre
Department of Medical Oncology
P.O. Box 2040
Dr. Molewaterplein 40
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 4897
a.vandergaast@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMC 03-048

Study information

Scientific title

Acronym

Xelox

Study hypothesis

For patients with metastatic or local-regional unresectable oesophageal 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.

Ethics approval

Approval received by the Medical Ethics Board of our hospital (Erasmus MC) on the 27th March 2003 (ref: EMC 03-048).

Study design

Phase II, non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oesophageal cancer

Intervention

Oxaliplatin 130 mg/m^2 Intravenous (IV) day one and capecitabine 1000 mg/m^2 twice daily orally days one to 14 (28 doses) repeated every three weeks.

Intervention type

Drug

Phase

Phase II

Drug names

Oxaliplatin and capecitabine

Primary outcome measures

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 oesophagus, oesophagogastric 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 measures

No secondary outcome measures

Overall trial start date

01/04/2003

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Metastatic or local-regional unresectable adenocarcinoma or squamous cell carcinoma oesophagus or gastric junction
2. At least one unidimensional measurable lesion greater than 20 mm (conventional), or greater than 10 mm (spiral)
3. World Health Organisation (WHO) grade zero to two
4. Adequate haematological, renal and hepatic functions

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

43

Participant exclusion criteria

1. Prior treatment with oxaliplatin or capecitabine; prior (neo)-adjuvant treatment for metastatic disease is allowed if completed at least six months prior to study start
2. Malabsorption syndrome or inability to take oral medication
3. Pre-existing motor or sensory neurotoxicity greater than grade one
4. Active infection

Recruitment start date

01/04/2003

Recruitment end date

01/10/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Medical Oncology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes