Locally Advanced or Metastatic Pancreatic Cancer
Conditions
Brief summary
A randomized phase II study to compare the efficacy and safety of SLOG or mFOLFIRINOX as a first-line treatment for patients with locally advanced and metastatic pancreatic cancer.
Detailed description
A total 130 patients (65 patients per arm) with locally advanced or metastatic pancreatic cancer will be enrolled in multiple hospitals of Taiwan. The primary endpoint is progression-free survival. The secondary endpoints are objective response rate, overall survival and safety profiles.
Interventions
DRUGS-1
Intervention is administered to patients in this Arm.
DRUGLeucovorin(oral )
Intervention is administered to patients in this Arm.
DRUGGemcitabine
Intervention is administered to patients in this Arm.
DRUGOxaliplatin
Intervention is administered to patients in this Arm.
DRUGIrinotecan
Intervention is administered to patients in this Arm.
DRUG5-FU
Intervention is administered to patients in this Arm.
DRUGLeucovorin(IV)
Intervention is administered to patients in this Arm.
Sponsors
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
Taipei Medical University Shuang Ho Hospital
Chang Gung Memorial Hospital
Tri-Service General Hospital
E-DA Hospital
National Health Research Institutes, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must have cyto-/histologically confirmed, locally advanced unresectable or metastatic adenocarcinoma of the pancreas (mPAC). Patients who have disease measurable or evaluable on x-ray, CT scan, or physical examination are eligible. 2. Patients must have no history of prior chemotherapy for PAC, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study. 3. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease. 4. Patients' baseline ECOG performance status must be 1. 5. Patients' life expectancy 12 weeks or greater. 6. Patients' age 20 and 80. 7. Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible. 8. Patients must agree to have indwelling venous catheter implanted. 9. Women or men and their partners of reproductive potential should agree to use an effective contraceptive method. 10. All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Exclusion criteria
1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy. 2. Patients with central nervous system metastasis 3. Patients with active infection 4. Pregnant or breast-nursing women 5. Patients with active cardiopulmonary disease or history of ischemic heart disease 6. Patients who have peripheral neuropathy \> Grade I of any etiology 7. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator. 8. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment 9. Patients who are under biologic treatment for their malignancy 10. Laboratory tests (hematology, chemistry) outside specified limits: 1. WBC ≤ 3 x 10³/mm³ 2. ANC ≤ 1.5 x 10³/mm³ 3. Platelets ≤ 100.000/mm³ 4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l) 5. GFR \< 60 mL/min 6. AST and/or ALT \> 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT \> 5 x ULN 7. Total bilirubin \> 2 x ULN 8. Albumin \< 2.5 g/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival (PFS) | Since this is an exploratory trial, it takes a sample size of 61 patients per arm entered in 2 years with a minimum 1 year of follow up to reach 75% power with type I error of 10% under the assumptions of exponential survival functions. | The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX) |
Countries
Taiwan
Outcome results
None listed