Pancreatic ductal adenocarcinoma
Conditions
Interventions
s body surface area as follows:<
1.25m2,60mg
1.25-1.5m2,80mg
1.5m2,100mg. S1 administered orally twice a day on days 1-7. The treatment cycle was repeated every 2 weeks. After 6 cycles of the GAS chemotherapy regimen, patients were reevaluated to assess resecta
Sponsors
Department of gastrointestinal Surgery, Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) a histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma (2) no distant metastasis (3) tumor with no contact with the major arteries including the superior mesenteric artery, celiac artery, or common hepatic artery on pretreatment computed tomography (CT) (4)tumor with no contact or less than 180 dgree contact with portal vein (5)More than 500 U/ml of pretreatment serum CA19-9 level (6)Initial treatment (7)0 or 1 of Performance status(ECOG) (8)Age between 20 and 79 (9)dequate hematological, hepatic, and renal functions by hemoglobin >8.0 g/dL, leucocytes >3,000 /mm3 and <12,000 /mm3, neutrophils >1,500 /mm3, platelets >100,000 /mm3, total bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase<Normal upper limit x2.5, serum creatinine <1.5mg/dL,
Exclusion criteria
Exclusion criteria: 1.Severe allergy for protcol drugs 2.Histly of active malignant disease within 5 years 3. Active infectious disease 4. >Geade2 of neuropahty 5. Ileus 6. Active interstitional pneumonia 7. Uncontrolable ascites and pleural effusion 8.Uncontrolable diabetes 9.Uncontrolable heart diseases 10.Histry of sevese neurological sidease 11.Pregnancy or possibility of pregnancy 12.Others who were judged to be not appropriate for participation to this clinicalrial by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over all survival after initiation of protocol therapy and median survival time | — |
Secondary
| Measure | Time frame |
|---|---|
| -Disease free survival after initiation of protocol therapy -Adverse events -postoperative complication with more than grade 3 -Response rate and normalization rate of tumormarkers after neoadjuvant chemotherapy -Histological responce (Evans grade) -Curative resection rate -Short time outcomes after surgical resection -Reoperation rate, readmission rate and mortality -Initiation and completion rate of adjuvant chemotherapy -Dose intensity | — |
Countries
Japan
Contacts
Public ContactNaru Kondo
Hiroshima University Hospital Gastrointestinal Surgery
Outcome results
None listed