Phase II trial of an alternating regimen consisting of first-line modified FOLFIRINOX and Gemcitabine plus nab-Paclitaxel for patients with metastatic pancreatic cancer

Phase II trial of an alternating regimen consisting of first-line modified FOLFIRINOX and Gemcitabine plus nab-Paclitaxel for patients with metastatic pancreatic cancer - KSCOT-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022936

Enrollment

Registered

2016-07-01

Start date

2016-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Alternating chemotherapy of modified FOLFIRINOX and gemcitabine plus nab-paclitaxel &lt

modified FOLFIRINOX regimen &gt

Fluorouracil:2400mg/m2 day 1, 15, q4weeks Leucovorin:200mg/m2 day 1, 15, q4weeks Irinotecan:150mg/m2 day 1, 15, q4weeks Oxaliplatin:85mg/m2day 1, 15, q4weeks &lt

Gemcitabine plus nab-Paclitaxel regimen &gt

Gemcitabine:1000mg/m2 day 1, 8, 15, q4weeks nab-Paclitaxel:125mg/m2 day 1, 8, 15, q4weeks Alternating chemotherapy every four weeks until progression disease

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma or adenosquamouscarcinoma. 2) Patients with unresectable recurrence or metastatic pancreatic cancer 3) Patients without any previous treatment (radiotherapy, chemotherapy). 4) Age between 20 and 70 years. 5) ECOG performance status 0 or 1. 6) Patients with measurable lesion. 7) Sufficient functions of important organs WBC<=12,000/mm3 Neurtophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=9.0g/dL AST<=2.5 X ULN ALT<=2.5 X ULN Total bilirubin<=1.25 X ULN Creatinine<=1.5mg/dl 8) Patients without clinical abnormality in urinalysis. 9) Patients without active hepatitis B. 10) Expected survival longer than 3 months. 11) Written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity reaction 2) Homozygote of UGT1A1*6 or UGT1A1*28, heterozygote of UGT1A1*6 and UGT1A1*28 3) Brain metastasis 4) Pulmonary fibrosis or interstitial pneumonia 5) Active infection 6) Other severe complications, such as heart failure, renal failure, hepatic failure, active ulcer, bowel obstruction and diabetes with clinically problem 7) Active another cancer 8) Required treatment with steroid 9) History of the peripheral arterial disease (Buerger disease, episodes of claudication) 10) History of collagenosis (SLE, systemic scleroderma, polyarteritis nodosa) 11) Pregnant or possibility pregnancy or nursing women 12) Men with hope of the pregnancy of the partner 13) Mental disorder which become problem on clinical practice 14) Physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival Objective response rate Safety	—

Countries

Japan

Contacts

Public ContactKeisuke Miwa

Kurume University Hospital Multidisciplinary Treatment Cancer Center

miwa_keisuke@kurume-u.ac.jp0942-35-3311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026