Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer.

Phase 2 study of S-1 and concurrent breath controlled intensity modulated radiation therapy for locally advanced unresectable pancreatic cancer. - Phase 2 study of S-1 and concurrent IMRT for locally advanced unresectable pancreatic cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032642

Enrollment

Registered

2018-05-21

Start date

2018-05-21

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

Pancreatic duct adenocarcinoma

Interventions

Patients receive concurrent IMRT with S-1. S-1

80mg/m2 on the irradiated day Radiotherapy

a total dose of 70 Gy in 28 fractions at gross tumor volume (GTV) and 50.4 Gy in 28 fractions at border of planning target volume (PTV)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven adenocarcinoma and consistent with adenocarcinoma by diagnostic imaging. 2) Diagnosed with locally advanced unresectable by contrast enhancement CT or MRI and suitable for concurrent chemoradiotherapy. 3) Diagnosed with inoperable cancer by gastroenterologist or surgeon. 4) Without obvious organ metastases by EOB-MRI or contrast enhancement CT. 5) ECOG PS of 0, 1 or 2. 6) Preserved oral intake function. 7) Adequate organ function. 8) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Previous history of radiotherapy for pancreatic cancer. 2) Moderate pleural effusion or ascites or cytologically proven pleural or abdominal dissemination. 3) Gastric or duodenal ulcer due to tumor invasion. 4) Active gastric or duodenal ulcer 5) Watery diarrhea 6) Patients requiring the administration of phenytoin, warfarin potassium or flucytosine. 7) Interstitial pneumonia or lung fibrosis. 8) Active infection. 9) Severe complication, such as heart disease, renal disease, and hepatic disease. 10) Patients requiring systemic steroids medication. 11) Psychosis. 12) Drug allergy. 13) Pregnant or lactating women of women of child bearing potential and men who want to get partner pregnant.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Completion rate, CA19-9 response rate, Progression free survival, distant metastasis free survival, Overall survival, Rate of adverse event	—

Countries

Japan

Contacts

Public ContactMasanori Someya

Sapporo Medical University, School of Mecidine Department of Radiology

someya@sapmed.ac.jp+81-11-611-2111

Outcome results

None listed

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