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

ISRCTN	ISRCTN07447845
DOI	https://doi.org/10.1186/ISRCTN07447845
Secondary identifying numbers	EMC 03-048, Trial NL448 (NTR488)

Submission date: 27/02/2007
Registration date: 27/02/2007
Last edited: 26/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A van der Gaast
Scientific

Erasmus Medical Centre
Department of Medical Oncology
P.O. Box 2040
Dr. Molewaterplein 40
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 463 4897
Email	a.vandergaast@erasmusmc.nl

Study information

Study design	Phase II, non-randomised, non-controlled, clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Phase II trial of combination therapy with oxaliplatin and capecitabine in patients with advanced oesophageal cancer
Study acronym	Xelox
Study objectives	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(s)	Approval received by the Medical Ethics Board of our hospital (Erasmus MC) on the 27th March 2003 (ref: EMC 03-048).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Oxaliplatin and capecitabine
Primary outcome measure	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 study start date	01/04/2003
Completion date	01/10/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	43
Total final enrolment	51
Key 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
Key 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
Date of first enrolment	01/04/2003
Date of final enrolment	01/10/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Centre

Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

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

Website	http://www.erasmusmc.nl/
"ROR"	https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		17/04/2007	26/08/2021	Yes	No

Editorial Notes

26/08/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.