Clinical trial to identify biomarkers to select patients with esophageal cancer for oxaliplatin and 5-fluorouracil chemotherapy prior to surgery
- Conditions
- Esophageal cancerCancerMalignant neoplasm of oesophagus
- Registration Number
- ISRCTN18146225
- Lead Sponsor
- Churchill Hospital
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29739952 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27045317
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 38
1. Histologically proven operable oesophageal adenocarcinoma/squamous cell carcinoma
2. Age greater than or equal to 18 years
3. Suitable for neo-adjuvant chemotherapy according to local protocols
4. Subjects must be free of any clinically significant disease other than oesophageal cancer that would interfere with the study evaluations
5. Adequate haematologic, renal and hepatic function as demonstrated by laboratory values performed within 14 days prior to the administration of chemotherapy:
5.1. Absolute neutrophil count (ANC) = 1500/mm3
5.2. Platelet count = 100,000/ mm3
5.3. Haemoglobin = 10g/dL
5.4. Urea and serum creatinine < 1.5 times upper limit of laboratory normal (ULN)
5.5. Creatinine clearance: more than 50ml (by Cockcroft Gault calc)
5.6. Total bilirubin < 1.5 times ULN
5.7. AST = 3 times ULN
5.8. Alkaline phosphatase < 2 times ULN
6. Patients must have given written informed consent
7. Women of child-bearing potential must use an acceptable method of birth control during the study
1. Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to starting the study drug(s))
2. Known dihydropyrimidine dehydrogenase deficiency
3. Subjects known to be HIV, Hep B or Hep C positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method