SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer

NCT03443492 | Completed Phase 2 DMC

• 1 other identifier: T5217
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)

  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.

Study Arms (2)

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

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.

Drug: Oxaliplatin; Drug: Irinotecan; Drug: 5-FU; Drug: Leucovorin(IV)

Interventions

S-1 DRUG

Intervention is administered to patients in this Arm.

SLOG

Leucovorin(oral ) DRUG

Intervention is administered to patients in this Arm.

SLOG

Gemcitabine DRUG

Intervention is administered to patients in this Arm.

SLOG

Oxaliplatin DRUG

Intervention is administered to patients in this Arm.

SLOG; mFOLFIRINOX

Irinotecan DRUG

Intervention is administered to patients in this Arm.

mFOLFIRINOX

5-FU DRUG

Intervention is administered to patients in this Arm.

mFOLFIRINOX

Leucovorin(IV) DRUG

Intervention is administered to patients in this Arm.

mFOLFIRINOX

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Medical University: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator
• E-DA Hospital: collaborator
• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• China Medical University Hospital: collaborator

Study Sites (1)

National Institute of Cancer Research

Miaoli, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31765987 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination); Gemcitabine; Oxaliplatin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Uracil; Pyrimidinones

Study Officials

• Chen Li-Tzong

  National Insitute of Cancer Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 23, 2018
• Study Start: March 26, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 30, 2025

Record last verified: 2019-11

Locations

TW (1)