esophageal cancer
Conditions
Interventions
Adjuvant treatment with six courses of S-1 and oxaliplatin.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Macroscopic radically resected adenocarcinoma of the esophagus - Completed neoadjuvant treatment with paclitaxel 50 mg/m2 and carboplatin AUC
Exclusion criteria
Exclusion criteria: - Any history or clinical signs of metastasis - A second malignancy interfering with the prognosis of current esophageal carcinoma - Known dihydropyrimidine dehydrogenase (DPD) deficiency or treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine. - - Significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients completing the preplanned number of 6 cycles of SOX. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of patients completing 6 cycles of S-1 (with or without oxaliplatin) - Dose modifications (i.e. delays, dose reductions, or interruptions) for S-1 - Dose modifications (i.e. delays, dose reductions, or interruptions) for oxaliplatin - Dose intensity of S-1. - Dose intensity of oxaliplatin - Toxicity - Disease free survival - Overall survival Exploratory: - Assessment of pharmacokinetics of S1 in relation to safety and efficacy. - Potential biomarker development based on assessment of archived tumor tissue and blood samples and the proposed mechanism of action of study drugs. | — |
Countries
Netherlands
Outcome results
None listed