Phase 2 trial of neo-adjuvant Oxaliplatin and 5-fluorouracil in oesophageal cancer - Oxali/5FU in Oesophageal Cancer
Phase 1
- Conditions
- Operable oesophageal cancer
- Registration Number
- EUCTR2005-001834-34-GB
- Lead Sponsor
- Oxford Radcliffe Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Operable oesophageal adenocarcinoma/squamous cell carcinoma.
Age greater than or equal to 18yrs.
Free of any other clinically significant disease.
Adequate haematologic, renal and hepatic function.
Selected for neo-adjuvant therapy at a MDT meeting.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Women who are pregnant or nursing (pregnency test to be performed within 24 hours prior to starting the study drug(s)).
Known dihydropyrimidine dehydrogenase deficiency.
Subjects known to be HIV, Hep B or Hep C positive
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To identify potential markers of clinical outcome for further evaluation in large scale studies;<br> Secondary Objective: Relationship between DNA repair gene haplotype and clinical outcome<br> Differences in pathways predicting outcome with oxaliplatin versus cisplatin<br> ;<br> Primary end point(s): Overall survival<br> Response to chemotherapy<br> Repair gene expression<br> Repair gene haplotype<br> Toxicity<br>
- Secondary Outcome Measures
Name Time Method