A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma - A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038585

Enrollment

Registered

2019-11-14

Start date

2019-11-14

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 and borderline resectable (BR-PV) pancreatic cancer

Interventions

To investigate the frequency of histological curative resection following chemoradiation using gemcitabine(1000mg/m2) and S1(60mg/m2) combined with hypofactionated radiotherapy(30Gy/10fr) during two w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with radiologically defined patentially resectable or borderline resectable (BR-PV) pancreatic ductal adenocarcinoma 2) Patients who have not undergone radiotherapy to the abdomen 3) Patients who have not undergone chemotherapy within 6 months 4) Patients with Performance status of 0/1 5) Patients with sustained organ function 6) Patients who received informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with pulmonary fibrosis or interstitial pneumonia 2) Patients with other active cancers 3) Patients who can not take medicine orally 4) Patients with severe allergies 5) Patients with watery diarrhea 6) Patients with severe co-morbid disease 7) Patients seems inadequate for this study by investigator(s)

Design outcomes

Primary

Measure	Time frame
Histological curative resection (R0 ratio)	—

Secondary

Measure	Time frame
Pathological responce rate, Incident of adverse event, Overall survival, Relapse free survival	—

Countries

Japan

Contacts

Public ContactHironobu Suto

Faculty of Medicine, Kagawa University Department of Gastroenterological Surgery

hsuto@med.kagawa-u.ac.jp087-898-5111

Outcome results

None listed

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