Overview

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

Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital
China Medical University Hospital
China Medical University Hospital,Taiwan
E-DA Hospital
Kaohsiung Chang Gung Memorial Hospital,Taiwan
Kaohsiung Medical University
Kaohsiung Medical University Hospital,Taiwan
Linkou Chang Gung Memorial Hospital, Taiwan
National Cheng Kung University Hospital,Taiwan
National Cheng-Kung University Hospital
National Taiwan University Hospital
National Taiwan University Hospital, Taiwan
Taipei Medical University Shuang Ho Hospital
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare,Taiwan
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Treatments:
Gemcitabine
Irinotecan
Leucovorin
Levoleucovorin
Oxaliplatin
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