Pancreatic cancer
Conditions
Interventions
One course of GEM administration (Day 1,8,15, 1000mg /m2) and neoadjuvant chemoradiotherapy of GEM (Day 1,8,15, 1000mg /m2) combined IMRT (3GyX15 times, 45Gy total) following pancreatectomy with lymph
Sponsors
Masui Toshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary tumor is confirmed to be pancreatic cancer from histology or cytology 2. No distant metastasis 3. Cases matching RPC expected to curative resection (R0 or R1). T1-3, stageIA-IIB according to UICC TNM classification 4. Age 20-80 years 5. ECOG Performance status 0 or 1 6. Capable of radical surgery 7. No previous treatment for pancreatic cancer 8. Capable of oral intake No clinical problems in ECG (latest value within 28 days before registration). 9. Main organs functions meet the following criteria Leukocytes >=3500 = 2000/mm3, Hemog lobin >= 9.0 g /dL, Platelets >= 100,000/mm3, Total bilirubin =50mL/min 10. Signed and dated informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1. Interstitial pneumonia or pulmonary fibrosis (latest evaluation by CT within 28 days before reg istration) 2. Prior history of radiation treatment in the upper abdomen and evaluated as inappropriate for the neoadjuvant chemoradiation. 3. Severe comorbidities (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, paralytic ileus, ileus, uncontrollable diabetes mellitus) 4. Uncontrollable pleural effusion or ascites that needs puncture 5. active malignant tumors (including that without recurrence in the past three years) Intramucosal carcinoma and carcinoma in situ are not dealt as active malignant tumors 6. Breast-feeding or pregnant, possibly pregnant, or women who do not agree to prevent conception, and both men and women without intention to use contraception during the period of the study 7. Cases with severe mental disorders 8. Additional cases the doctor deems inappropriate for the participation of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time from the first day of the protocol therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS), negative marg in rate (R0 rate), response rate (RR), histological response rate, incidence rate of acute disease, incidence rate of late-onset disease, Risk organ failure rate, treatment-related death rate / early death rate / Grade 4 non-hematological toxicity rate | — |
Contacts
Public ContactToshihiko Masui
Kyoto University Hospital
Outcome results
None listed