pancreatic neoplasm
Conditions
Interventions
Patients receive 30-minute infusion of gemcitabine (1000 mg/m2/day, days 1, 8, and 15) every 4 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable tox
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are included if they meet the following criteria: histologically or cytologically proven exocrine pancreatic cancer, locally advanced: T4 (UICC) without obvious organ metastasis, aged 20 years or over, definitive chemoradiotherapy can be indicated: all pancreas lesions and lymph node metastases are included in the radiation field, 15 cm on a side, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. In recurred cases, sufficient organ function. They have no history of radiotherapy, chemotherapy and surgery for pancreas except for exploraratory laparotomy, choledochojejunostomy and gastrojejunostomy. They provided written informed consent.
Exclusion criteria
Exclusion criteria: Patients are excluded if they meet the following criteria: They have obvious ascetic or pleural effusion, lung fibrosis or pneumonitis, uncontrolled diabetes mellitus in spite of using more than 40 unit insulin, Classification of New York Heart Association (NYHA) of III or IV, myocardial infarction within 6 months before this trial, synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, or severe mental disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical benefit response (CBR), CA19-9 response, adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Ishiii, MD, PhD
JCOG0506 Coordinating Office Medical Oncology Division, National Cancer Institute Hospital
Outcome results
None listed