Clinical trial NCT03443492: SLOG Vs MFOLFIRINOX As the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Official title: A Phase II Randomized Study of SLOG Vs MFOLFIRINOX As the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced or Metastatic Pancreatic Cancer
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Taipei Veterans General Hospital, Taiwan
name: China Medical University Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Medical University
name: Taipei Medical University Shuang Ho Hospital
name: Chang Gung Memorial Hospital
name: Tri-Service General Hospital
name: E-DA Hospital
First posted: 2018-02-23
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Miaoli
country: Taiwan
facility: National Institute of Cancer Research
Study officials:
affiliation: National Insitute of Cancer Research
name: Chen Li-Tzong
role: STUDY_CHAIR
References:
citation: 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.