Pancreatic cancer
Conditions
Interventions
Intensity-modulated radiotherapy(IMRT) Concurrent chemotherapy with Gemcitabine Induction chemotherapy with Gemcitabine
Sponsors
Department of Therapeutic Radiology, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pancreatic cancer proven with pathological or cytological examination with diagnostic imaging. 2) Clinical stage (T3-4, N0, M0) (UICC), unresectable pancreatic cancer (medically inoperable T3 patients are also allowed on to this study 3) Patients have tumors measurable by RECIST criteria 4) Tumor size </= 6cm 5) Np apparent bowel invasion of tumors on CT or endscopic findings 6) Patients' age must be >/=18 and <80 years old. ECOG performance status; 0-1 7) Without history of previous chemotherapy, but patients who have received up to one cycle of single agent gemcitabine remain eligible. 8) Without history of previous abdominal radiation therapy 9) Adequate organ functions; white blood cells >/= 3000/m3 neutrophil >=2000/m3 platelets >/= 100,000/m3 hemoglobin >/= 10.0g/dl AST </= 3.0 X ULN ALT </= 3.0 X ULN total bilirubin </= 2.0mg/dL 10) Patients must be aware of the investigational nature of therapy and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with active double cancer (double cancer with no more than 5-year disease-free period. However, carcinoma in situ judged to be cured by local treatment, or intra-mucosal cancer-equivalent lesion are not to be included in active double cancer). 2) Patients with active bacterial infection requiring treatment. 3) Patients with severe cardiac disease 4) Patients with severe drug allergy history 5) Patients with unstable and uncontrollable diabetic mellitus, hypertension, kidney disease, liver disease. 6) Patients with intersitial pneumonia or pulmonary fibrosis detectable on chest radiography 7) Women during pregnancy or breast-feeding, or patients who wish pregnancy 8) Patients that physicians consider inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (the incidence of dose limiting toxicity) | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate, overall survival time, progression-free survival time, completion rate of chemotherapy, incidence of adverse events within 6 months from the start day of treatment, Rate of palliative efficacy (pain relief), rate of CA19-9 regression, The accuracy of the new technique of radiotherapy | — |
Countries
Japan
Contacts
Public ContactKeiko SHibuya
Kyoto University Hospital Therapeutic Radiology
Outcome results
None listed