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

Conditions

• Locally Advanced or Metastatic Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

20 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• S-1 — DRUG
  Intervention is administered to patients in this Arm.
• Leucovorin(oral ) — DRUG
  Intervention is administered to patients in this Arm.
• Gemcitabine — DRUG
  Intervention is administered to patients in this Arm.
• Oxaliplatin — DRUG
  Intervention is administered to patients in this Arm.
• Irinotecan — DRUG
  Intervention is administered to patients in this Arm.
• 5-FU — DRUG
  Intervention is administered to patients in this Arm.
• Leucovorin(IV) — DRUG
  Intervention is administered to patients in this Arm.

Study Details

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.

Key Dates

Start date

Mar 26, 2018

Status verified

Nov 2019

Primary completion

Nov 30, 2019

Completion

Nov 30, 2019

Study Design

Enrollment

130 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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
• Experimental: 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.

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. ]