Randomized phase II trial of neoadjuvant Chemotherapy with Gemcitabine and S-1 vs. without neoadjuvant chemotherapy in patients with resectable pancreatic cancer

Randomized phase II trial of neoadjuvant Chemotherapy with Gemcitabine and S-1 vs. without neoadjuvant chemotherapy in patients with resectable pancreatic cancer - Randomized phase II trial of GS neoadjuvant therapy for patients with resectable pancreatic cancer (CAP-004)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009822

Enrollment

Registered

2013-01-20

Start date

2012-12-20

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

Resectable pancreatic cancer

Interventions

Gemcitabine and S-1 combination neoadjuvant chemotherapy (GS group): S-1 60mg/m2/day for 14days and gemcitabine 1000mg/m2 at day8 and 15 within 21days as 1 course. total 3 courses followed by surgic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Resectable pancreatic cancer in preoperative imaging diagnosis 2) Pancreatic cancer without distant metastasis 3) Imaging diagnosis shows following criteria a. Without abutment to major arteries such as SMA, HA and CEA b. Portal vein or SMV stenosis within 50% in diameter 4) Performance Status 0 or 1 5) Adequate hematologic, renal and hepatologic function 6) Provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction 2. Sever myelosuppression 3. Pregnancy, breast feeding, or women who desire to preserve fecundity 4. Sever renal dysfunction 5. Sever hepatic dysfunction 6. With other anticancer treatment 7. With flucitocine or warfarin potassium treatment 8. With pulmonary fibrosis 9. With history of radiation to lung field 10. Active infectious disease 11. Massive pleural effusion 12. With distant metastasis 13. Active malignancies other than pancreatic cancer 14. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure 15. Severe diabetes or hypertension 16. Severe mental disorder 17. Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Two year disease progression free survival rate	—

Secondary

Measure	Time frame
overall survival, disease free survival, R0 resection rate, R0+1 resection rate, histological efficacy of chemotherapy, Adverse events, recurrent location, tumor marker level, relative intensity, surgical complication rate, responce rate	—

Countries

Japan

Contacts

Public ContactHideyuki Yoshitomi

Chiba unviersity, Graduate School of Medicine Department of General Surgery

yoshitomi@faculty.chiba-u.jp81-43-222-7171

Outcome results

None listed

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