Phase I/II study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1)

Phase I/II study of Gemcitabine and S-1 (GS therapy) as Neoadjuvant chemoradiationtherapy for borderline resectable pancreatic cancer (Prep-03/NS014-1) - Neoadjuvant GS chemoradationtherapy for borderline resectable pancreatic cancer : Prep-03/NS014-1

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014498

Enrollment

Registered

2014-07-07

Start date

2014-08-04

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 resectable pancreatic cancer

Interventions

Neoadjuvant chemoradiationtherapy withgemcitabine and S-1 followed by surgery.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) invasive ductal carcinoma of the pancreas 2) no distant metastasis 3) R0/1 resectable 4) borderline resectable Pancreatic cancer 5) all adult who anticipate to undergo pancreatectomy 6) no prior therapy 7) ECOG performance status of 0 or 1 8) adequate organ function 9) oral intake is possible 10) written informed consent

Exclusion criteria

Exclusion criteria: 1) pulmonary fibrosis or interstitial pneumonitis 2) Active double cancer 3) Active infection 4) HBs antigen positive 5) patients are using flucytosine, phenytoin, warfarin 6) pregnant females, possibly pregnant females

Design outcomes

Primary

Measure	Time frame
Phase I:Maximum Tolerated Dose, Recommended Dose Phase II: R0 resection rate	—

Countries

Japan

Contacts

Public ContactKei Nakagawa

Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology

kein_h11@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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