A phase 2 study of combination neoadjuvant chemotherapy with gemcitabine S-1 and leucovorin in patients with borderline and locally advanced pancreatic cancer

A phase 2 study of combination neoadjuvant chemotherapy with gemcitabine S-1 and leucovorin in patients with borderline and locally advanced pancreatic cancer - NAC-GSL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012480

Enrollment

Registered

2013-12-04

Start date

2013-12-04

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

Borderline and Locally advanced pancreatic cancer

Interventions

GEM+S-1+LV combination therapy GEM:1,000mg/m2, day1 S-1:80mg/day(BSA&lt

1.25/m2) 100mg/day(1.25/m2=&lt

BSA&lt

1.5/m2) 120mg/day(BSA=&gt

1.5/m2), day1-7 LV:50mg/day, day1-7 repeated every 2weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with pancreatic cancer without prior treatment 2) Patients with pathologically proven pancreatic cancer 3) Borderline and locally advanced pancreatic cancer 4) Without distant metastasis 5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 6) Patients of age >= 20 years 7) Patients who can eat 8) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutophils >=1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal 9) Estimated survival > 2months 10) Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 1) Patients with systolic blood pressure < 100mmHg 2) Patients with an active concomitant infection 3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diarrhea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 9) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
Resection rate, Progression free survival, Overall survival, Response rate, Disease control rate, Adverse events, Intra-operative complication, Post-operative complication, Operative time, Postoperative length of stay	—

Countries

Japan

Contacts

Public ContactKei Saito

The University of Tokyo Hospital Department of Gastroenterology

kesaitou-nii@umin.ac.jp03-3815-5411

Outcome results

None listed

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