Invasive ductal adenocarcinoma of pancreas
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with resected pancreatic cancer that was a histologically verified invasive ducal carcinoma of the pancreas (StageI/II or stage III combined resected with artery based on UICC ver.8). 2. Local residual tumor classified as R0 or R1. 3. Cytologic examination negative upon intraoperative peritoneal lavage 4. Until 10 weeks after surgery 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 6. Age of 20 years or above 7. Written informed consent given
Exclusion criteria
Exclusion criteria: 1. Severe drug hypersensitivity or drug allergy 2. Multiple primary cancers within 5 years. 3. Severe infection 4. With watery diarrhea 5. Interstitial pneumonia or pulmonary fibrosis 6. With uncontrollable pleural effusion or ascites 7. With uncontrollable diabetes mellitus 8. With severe heart failure, angina, hypertension, arrhythmia 9. Walking akinesia 10. With severe malnutrition 11. With severe neurological/psychological symptoms 12. Pregnant or lactating women or women with unknown or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The completion rate of four courses of S-1 adjyvant chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relative dose intensity of S-1: Until 6 months after the first day of adjuvant therapy 2. Recurrence free survival time 3. Overall survival time 4. Safety of the protocol therapy of this study: Until 6 months after the first day of adjuvant therapy 5. Questionnaires about fraility, EORTC QLQ-C30 SF-36 | — |
Countries
Japan
Contacts
Wakayama Medical University Second Department of surgery