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

Phase 2

Completed

• Conditions: Oesophageal cancer; Cancer

• Registration Number: ISRCTN07447845
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

2007 Results article in https://doi.org/10.1038/sj.bjc.6603750 (added 26/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-10-01
• Study Start: 2007-02-27
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 51

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified