Status:
COMPLETED
SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Conditions:
Locally Advanced or Metastatic Pancreatic Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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. Th...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
- Patients' baseline ECOG performance status must be 1.
- Patients' life expectancy 12 weeks or greater.
- Patients' age 20 and 80.
- Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
- Patients must agree to have indwelling venous catheter implanted.
- Women or men and their partners of reproductive potential should agree to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
Exclusion
- 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.
- Patients with central nervous system metastasis
- Patients with active infection
- Pregnant or breast-nursing women
- Patients with active cardiopulmonary disease or history of ischemic heart disease
- Patients who have peripheral neuropathy \> Grade I of any etiology
- 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.
- 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
- Patients who are under biologic treatment for their malignancy
- Laboratory tests (hematology, chemistry) outside specified limits:
- WBC ≤ 3 x 10³/mm³
- ANC ≤ 1.5 x 10³/mm³
- Platelets ≤ 100.000/mm³
- Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
- GFR \< 60 mL/min
- AST and/or ALT \> 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT \> 5 x ULN
- Total bilirubin \> 2 x ULN
- Albumin \< 2.5 g/dL
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03443492
Start Date
March 26 2018
End Date
November 30 2019
Last Update
December 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Cancer Research
Miaoli, Taiwan