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

N

National Health Research Institutes, Taiwan

Status and phase

Unknown
Phase 2

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Treatments

Drug: Irinotecan
Drug: Leucovorin(IV)
Drug: Leucovorin(oral )
Drug: Oxaliplatin
Drug: 5-FU
Drug: S-1
Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT03443492
T5217

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

130 participants in 2 patient groups

SLOG
Experimental group
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
Treatment:
Drug: Gemcitabine
Drug: S-1
Drug: Oxaliplatin
Drug: Leucovorin(oral )
mFOLFIRINOX
Experimental group
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.
Treatment:
Drug: 5-FU
Drug: Oxaliplatin
Drug: Leucovorin(IV)
Drug: Irinotecan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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