Operable oesophageal cancer
Conditions
Interventions
Trade Name: Eloxatin
Product Name: Eloxatin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Oxaliplatin
Conce
Sponsors
Oxford Radcliffe Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify potential markers of clinical outcome for further evaluation in large scale studies; Secondary Objective: Relationship between DNA repair gene haplotype and clinical outcome Differences in pathways predicting outcome with oxaliplatin versus cisplatin ; Primary end point(s): Overall survival Response to chemotherapy Repair gene expression Repair gene haplotype Toxicity | — |
Countries
United Kingdom
Outcome results
None listed