Locally Advanced Pancreatic Cancer
Conditions
Interventions
4.6Gy(RBE) per day, A total of 55.2Gy(RBE) / 12 Fr Chemotherapy
Three consecutive administration of Gemcitabine (1000mg/m2) once a week and no administration in the fourth week
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who is diagnosed as invasive pancreatic ductal adenocarcinoma by cytological* or histopathological biopsy, OR, those who clinically diagnosed as primary malignant tumor in the pancreas, except for lymphoma * Eligible for class IV or V 2) Patient who shows no distant metastasis by imaging studies (N0-1M0) 3) Patient who fulfills either following conditions; - Locally advanced pancreatic cancer with non-curative resection - Locally advanced pancreatic cancer with curative resection, but inoperative case due to complications - Patients with locally advanced pancreatic cancer who deny the resection 4) 20 years old or more at trial registration 5) 0 to 2 of Performance Status (ECOG) 6) Patient who fulfills all the following conditions if he/she undergoes concomitant chemotherapy All the laboratory data are measured within 7 days before trial registration. (a) White blood cells >= 3500 /mm3 (b) Hemoglobin >= 9.0 g/dl (c) Platelet >= 100000 /mm3 (d) Albumin >= 3.0 g/dl (e) Total bilirubin Patient with the history of drainage procedure: =< 2 mg/dl Patient without the history of drainage procedure: =< 3 mg/dl (f) GOT(AST) Patient with the history of drainage procedure: =< 100 IU Patient without the history of drainage procedure: =< 150 IU (g) Serum creatinine =< 1.2 mg/dl *These conditions are NOT required for Patient without concomitant chemotherapy. 7) Patient who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B) 8) Written consent obtained for the participation in this study
Exclusion criteria
Exclusion criteria: 1) Patient with direct invasion in the gastrointestinal tract which fulfills either following conditions; (a) Endoscopic findings of obvious invasion in stomach and duodenum (b) Imaging findings, including those by computed tomography, of invasion inside the gastrointestinal tract 2) Obvious peritoneal dissemination, except for small amount of ascites or negative cytology of ascites 3) Gastric or duodenal ulcer, except for ulcer scar 4) Metallic stent for occlusive jaundice 5) Open injury or active and intractable infection in the target lesion 6) Severe complications such as severe cerebrovascular disease, intractable diabetes, severe cardiovascular disease, angina, myocardial infarction within 3 months from the onset, severe liver dysfunction, severe psychiatric disease if concomitant radiochemotherapy is selected, Severe complication which influences irradiation of carbon-ion beam such as psychiatric disease if carbon-ion radiotherapy alone is selected 7) Active and untreated double cancer, except for intraepithelial carcinoma, intramucinous carcinoma or malignancy controlled for a long-term 8) Medically or psychologically unsuitable conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who developed grade 2 or severe adverse events in the upper gastrointestinal tract within a year after irradiation (3 years of observation period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival 2) Local control survival 3) Progression free survival 4) Adverse event rate | — |
Countries
Japan
Contacts
Public ContactHiroyuki Katoh
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center
Outcome results
None listed