Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer

Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer - Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resecatble pancreatic cancer (JASPAC 04)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014894

Enrollment

100

Registered

2014-08-19

Start date

2013-05-01

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

resectable pancreatic cancer

Interventions

chemoradiotherapy with S-1 as neoadjuvant treatment Gemcitabine and S-1 combination therapy as neoadjuvant treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Invasive ductal adenocarcinoma of the pancreas based on the images, 2 Adenocarcinoma is proven by biopsy or cytology, 3 Radiation field for the primary lesion and lymph node metastasis is lemited within 10 cm, 4 No gastric or duodenal ulcer 5 No cancerous invasion into stomach or duodenum, etc

Exclusion criteria

Exclusion criteria: 1 Treatment history with gemcitabine or fuluoruracil, 2 Use of flucytosine, phenytoin, and warfarin potassium, 3 Fibroid lung or interstitial pneumonia, 4 Pleural lung or ascites 5 Watery diarrhea, etc

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival	—

Secondary

Measure	Time frame
overall survaival (2-year survival rate), R0 or 1 resection rate, pathological response rate, adverse event of neoadjuvant therapy, morbidity rate of surgery, non-hematologic adverse event of grade 4, early mortality rate, treatment-related mortality rate	—

Countries

Japan

Contacts

Public ContactKATSUHIKO UESAKA

Shizuoka Cancer Center Hospital Division of Hepato-Biliary-Pancreatic Surgery

k.uesaka@scchr.jp055-989-5222

Outcome results

None listed

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