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

National Health Research Institutes, Taiwan

Status and phase: Completed; Phase 2

Conditions: Locally Advanced or Metastatic Pancreatic Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03443492

T5217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. 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.
3. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
4. Patients' baseline ECOG performance status must be 1.
5. Patients' life expectancy 12 weeks or greater.
6. Patients' age 20 and 80.
7. Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
8. Patients must agree to have indwelling venous catheter implanted.
9. Women or men and their partners of reproductive potential should agree to use an effective contraceptive method.
10. All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion criteria

1. 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.

2. Patients with central nervous system metastasis

3. Patients with active infection

4. Pregnant or breast-nursing women

5. Patients with active cardiopulmonary disease or history of ischemic heart disease

6. Patients who have peripheral neuropathy > Grade I of any etiology

7. 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.

8. 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

9. Patients who are under biologic treatment for their malignancy

10. Laboratory tests (hematology, chemistry) outside specified limits:

    1. WBC ≤ 3 x 10³/mm³
    2. ANC ≤ 1.5 x 10³/mm³
    3. Platelets ≤ 100.000/mm³
    4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    5. GFR < 60 mL/min
    6. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
    7. Total bilirubin > 2 x ULN
    8. Albumin < 2.5 g/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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: S-1

Drug: Oxaliplatin

Drug: Gemcitabine

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: Irinotecan

Drug: Leucovorin(IV)

Drug: Oxaliplatin

Drug: 5-FU