locally advanced adenocarcinoma of the esophagogastric junction
Conditions
Interventions
Neoadjuvant chemotherapy with DOS followed by surgical resection
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven adenocarcinoma by endoscopic biopsy 2) Tumor epicenter located within 5cm above or below the gastroesophageal junction determined by endoscopy or barium swallow 3) Clinical tumor depth of T3 or 4a determined by computed tomography and endoscopy 4) R0 resection or R1 resection solely by CY1 can be obtained 5) ECOG performance status of 0 or 1 6) No prior chemotherapy or radiotherapy for any cancer and no prior surgery for esophageal or gastric cancer 7) No severe organ dysfunction
Exclusion criteria
Exclusion criteria: 1) Concurrent cancers 2) Pregnant or breast-feeding female. Male or female who wants to have children 3) Psychiatric disorders or severe psychiatric symptoms 4) Continuous use of systemic steroid 5) Positive for HBs antigen 6) Continuous use of flucytosine or phenytoin or warfarin 7) Severe drug allergy 8) Infectious disease or suspicion of infectious disease 9) Acute myocardial infarction within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I:Occurrence rate of DLT at each dose level Phase II:R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I:Occurrence rate of adverse events Phase II:3 year overall survival rate, 3 year relapse free survival rate, Completion rate of the protocol therapy, Response rate of neoadjuvant chemotherapy, Pathological responce of neoadjuvant chemotherapy, Rate of occurrence of adverse events | — |
Countries
Japan
Contacts
Public ContactMasahiro Niihara
Kitasato University School of Medicine Department of Upper Gastrointestinal Surgery
Outcome results
None listed