Back to resultsSLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer (Pancreas)
Primary Purpose
Locally Advanced or Metastatic Pancreatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
S-1
Leucovorin(oral )
Gemcitabine
Oxaliplatin
Irinotecan
5-FU
Leucovorin(IV)
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- National Institute of Cancer Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SLOG
mFOLFIRINOX
Arm Description
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
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.
Outcomes
Primary Outcome Measures
progression free survival (PFS)
The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)
Secondary Outcome Measures
Full Information
NCT ID
NCT03443492
First Posted
February 8, 2018
Last Updated
August 20, 2019
Sponsor
National Health Research Institutes, Taiwan
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT03443492
Brief Title
SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Acronym
Pancreas
Official Title
A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase II Randomized Study.Primary objective:to investigate the 6-month progression-free survival (PFS) rate i patients receiving SLOG or mFLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer.
Detailed Description
A total of 130 patients (65patients in each arm) will be calculated, based on the assumption of a 6-month PFS rate of 45% with mFOLFIRINOX vs 60% wuth SLOG, to achieve 75% power, with a drop-out rate of 10%. Two-sided test was performed with type I error=0.10.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SLOG
Arm Type
Experimental
Arm Description
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
Arm Title
mFOLFIRINOX
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
Intervention is administered to patients in this Arm.
Intervention Type
Drug
Intervention Name(s)
Leucovorin(oral )
Intervention Description
Intervention is administered to patients in this Arm.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Intervention is administered to patients in this Arm.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Intervention is administered to patients in this Arm.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Intervention is administered to patients in this Arm.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Intervention is administered to patients in this Arm.
Intervention Type
Drug
Intervention Name(s)
Leucovorin(IV)
Intervention Description
Intervention is administered to patients in this Arm.
Primary Outcome Measure Information:
Title
progression free survival (PFS)
Description
The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Li-Tzong
Organizational Affiliation
National Insitute of Cancer Research
Official's Role
Study Chair
Facility Information:
Facility Name
National Institute of Cancer Research
City
Miaoli
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31765987
Citation
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.
Results Reference
derived
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SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
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