Locally Advanced or Metastatic Pancreatic CancerPhase 2PancreasNCT03443492
SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
A Phase 2 study testing S-1, Leucovorin(oral ) and Gemcitabine in people with Locally Advanced or Metastatic Pancreatic Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Locally Advanced or Metastatic Pancreatic Cancer
- What is being tested?
- S-1, Leucovorin(oral ) and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2018to 30 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
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.
Read the 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.
- Being tested
- S-1, Leucovorin(oral ), Gemcitabine, Oxaliplatin, Irinotecan
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Intervention is administered to patients in this Arm.
Leucovorin(oral )Drug
Intervention is administered to patients in this Arm.
GemcitabineDrug
Intervention is administered to patients in this Arm.
OxaliplatinDrug
Intervention is administered to patients in this Arm.
IrinotecanDrug
Intervention is administered to patients in this Arm.
5-FUDrug
Intervention is administered to patients in this Arm.
Leucovorin(IV)Drug
Intervention is administered to patients in this Arm.
| Study group | Role | What they receive |
|---|---|---|
| SLOG | Experimental | 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 Receives: Drug: S-1; Drug: Leucovorin(oral ); Drug: Gemcitabine; Drug: Oxaliplatin |
| mFOLFIRINOX | Experimental | 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. Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: 5-FU; Drug: Leucovorin(IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start26 Mar 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- 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 (TSGH), E-DA Hospital
- Responsible party
- Sponsor
- Investigators
- Chen Li-Tzong, Study chair, National Insitute of Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443492
- Sponsor's protocol ID
- T5217
- Acronym
- Pancreas
- Status last verified
- Nov 2019
- First submitted
- 8 Feb 2018
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31765987
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03443492
- Acronym / sponsor ID
- Pancreas / T5217
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- 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 (TSGH), E-DA Hospital
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLOG | Experimental | Drug: S-1, Drug: Leucovorin(oral ), Drug: Gemcitabine, Drug: Oxaliplatin800 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 |
| mFOLFIRINOX | Experimental | Drug: Oxaliplatin, Drug: Irinotecan, Drug: 5-FU, Drug: Leucovorin(IV)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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1Intervention is administered to patients in this Arm. | Drug | SLOG |
| Leucovorin(oral )Intervention is administered to patients in this Arm. | Drug | SLOG |
| GemcitabineIntervention is administered to patients in this Arm. | Drug | SLOG |
| OxaliplatinIntervention is administered to patients in this Arm. | Drug | SLOG, mFOLFIRINOX |
| IrinotecanIntervention is administered to patients in this Arm. | Drug | mFOLFIRINOX |
| 5-FUIntervention is administered to patients in this Arm. | Drug | mFOLFIRINOX |
| Leucovorin(IV)Intervention is administered to patients in this Arm. | Drug | mFOLFIRINOX |
Primary outcome
progression free survival (PFS)
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.
The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 31765987Chiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Li-Tzong study chair
National Insitute of Cancer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1, Leucovorin(oral ) and Gemcitabine in people with Locally Advanced or Metastatic Pancreatic Cancer, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.