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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053195

Enrollment

Registered

2023-12-22

Start date

2023-04-01

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 and borderline resectable (BR-PV) pancreatic cancer

Interventions

To investigate the pathological tumor response of cases that underwent neoadjuvant chemoradiation treatment using gemcitabine(800mg/m2) and S1(60mg/m2) combined with radiotherapy(50Gy/25fr) followed b

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
Pathological tumor response to neoadjuvant chemoradiotherapy	—

Secondary

Measure	Time frame
Completion and adverse event rate, pathological tumor response, histological curative resection (R0 ratio), morbidity rate, recurrence free survival, overall survival	—

Countries

Japan

Contacts

Public ContactHironobu Suto

Faculty of Medicine, Kagawa University Department of Gastroenterological Surgery

suto.hironobu@kagawa-u.ac.jp087-898-5111

Outcome results

None listed

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