SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
NCT ID: NCT03443492
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2018-03-26
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SLOG
800 mg/m2 gemcitabine at a fixed rate of 10 mg/m2/min followed by a 2-hour intravenous infusion of oxaliplatin on day 1 plus twice daily oral S-1 80-120 mg/day (based on BSA) and oral leucovorin 30 mg twice a day on day 1 to day 7, every 14 days as a cycle
S-1
Intervention is administered to patients in this Arm.
Leucovorin(oral )
Intervention is administered to patients in this Arm.
Gemcitabine
Intervention is administered to patients in this Arm.
Oxaliplatin
Intervention is administered to patients in this Arm.
mFOLFIRINOX
oxaliplatin at a dose of 85 mg/m2, given as a 2-hour infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute infusion. The treatment was immediately followed by a continuous intravenous infusion via central venous catheter of leucovorin 400 mg/m2 given as a 2-hour infusion and 5-FU 2400 mg/m2 over a 46-hour period on day 1 every 14 days/cycle.
Oxaliplatin
Intervention is administered to patients in this Arm.
Irinotecan
Intervention is administered to patients in this Arm.
5-FU
Intervention is administered to patients in this Arm.
Leucovorin(IV)
Intervention is administered to patients in this Arm.
Interventions
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S-1
Intervention is administered to patients in this Arm.
Leucovorin(oral )
Intervention is administered to patients in this Arm.
Gemcitabine
Intervention is administered to patients in this Arm.
Oxaliplatin
Intervention is administered to patients in this Arm.
Irinotecan
Intervention is administered to patients in this Arm.
5-FU
Intervention is administered to patients in this Arm.
Leucovorin(IV)
Intervention is administered to patients in this Arm.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
China Medical University Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Kaohsiung Medical University
OTHER
Taipei Medical University Shuang Ho Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Tri-Service General Hospital
OTHER
E-DA Hospital
OTHER
National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Chen Li-Tzong
Role: STUDY_CHAIR
National Insitute of Cancer Research
Locations
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National Institute of Cancer Research
Miaoli, , Taiwan
Countries
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References
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Chiang NJ, Tsai KK, Hsiao CF, Yang SH, Hsiao HH, Shen WC, Hsu C, Lin YL, Chen JS, Shan YS, Chen LT. A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma-TCOG T1211 study. Eur J Cancer. 2020 Jan;124:123-130. doi: 10.1016/j.ejca.2019.10.023. Epub 2019 Nov 22.
Other Identifiers
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T5217
Identifier Type: -
Identifier Source: org_study_id