locally advanced pancreatic cancer
Conditions
Interventions
Arm A: mFOLFIRINOX (2-hour IV of oxaliplatin at 85 mg/m2, 2-hour IV of leucovorin at 200 mg/m2 and 1.5-hour IV of irinotecan 150 mg/m2, followed by a continuous IV of 5-FU at 2,400 mg/m2 over 46 hours
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven adenocarcinoma and consistent with papillary adenocarcinoma, tubular adenocarcinoma, poor differentiated adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging 2) Without obvious organ metastasis (UICC-M0) by chest CT and abdominal/pelvic CT 3) Diagnosed as UICC-T4 or UICC-T3 with invasion to common hepatic artery, hepatic artery proper, or portal vein by abdominal and pelvic CT 4) Without ascites/pleural effusion by chest CT and abdominal/pelvic CT 5) A mesurable lesion is not required 6) Age from 20 to 75 years. 7) ECOG performance status of 0 or 1 8) No diarrhea 9) No peripheral sensory neuropathy and peripheral motor neuropathy 10) No prior surgical treatment for pancreatic cancer 11) No previous chemotherapy or radiotherapy for other malignancies 12) UGT1A1 genotype of neither *6/*6, *28/*28, nor *6/*28 13) Adequate function of major organs 14) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Pyrexia of 38 degrees centigrade or higher. 4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 5) Severe psychological disorder. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT 8) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes and poorly controlled hypertension) 9) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 10) Allergy to iodine and gadolinium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (proportion of 1-year survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate in patients with target lesions, CA19-9 response, distant metastasis-free survival, progression-free survival, adverse events, dose-intensity, treatment-related death, early death, grade 4 non-hematological toxicity | — |
Countries
Japan
Contacts
Public ContactAkira FUKUTOMI
JCOG1407 Coordinating Office Shizuoka Cancer Center, Divison of Gastrointestinal Oncology
Outcome results
None listed