A Phase II trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

A Phase II trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer - S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000486

Enrollment

Registered

2006-09-12

Start date

2006-07-01

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

Locally advanced pancreatic cancer

Interventions

Concurrent radiotherapy with S-1 and maintenance therapy of S-1 was administered until disease progression or unacceptable toxicity. Concurrent radiotherapy with S-1: S-1

80mg/m2 on the irradiated day. Radiotherapy

a total dose of 50.4 Gy in 28 fractions over 5.5 weeks. Maintenance therapy of S-1: 80mg/m2 for 28 days, followed by a rest period of 14 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients eligible for study entry had locally advanced pancreatic cancer. Eligibility criteria were: 1)Histologically or cytologically proven adenocarcinoma 2)No prior treatment for pancreatic cancer 3)All pancreas lesions and lymph node metastases are included in the radiation field, 10 x 10 cm 4)Aged 20 years or over 5)An Eastern Cooperative Oncology Group performance status of 0-2 6)Adequate oral intakes 7)Sufficient organ function: leukocytes >= 3,500 /mm3, hemoglobin >= 9 g/dL, platelets >= 100,000 /mm3, serum albumin >= 3.0 g/dL, serum total bilirubin <= 2.0 mg/dL (or 3.0mg/dL if biliary drainage were present), serum transaminases (aspartate aminotransferase (AST) / alanine aminotransferase (ALT)) <= 100 U/L (or 150U/L if biliary drainage were present), and serum creatinine <= upper normal limit 8)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Watery diarrhea 2)Use of phenytoin, warfarin potassium, or flucytosine 3)Pleural effusion or ascites 4)Active infection 5)Active concomitant malignancy 6)Active gastroduodenal ulcer 7)Severe complication, such as heart disease, renal disease, and hepatic disease 8)Severe mental disorder 9) Severe allergic reaction to drug 10)Active concomitant malignancy, pregnant and lactating females, and females of childbearing age unless using effective contraception

Design outcomes

Primary

Measure	Time frame
Survival and adverse events	—

Secondary

Measure	Time frame
Progression free survival, response rate, and CA19-9 response.	—

Countries

Japan

Contacts

Public ContactMasafumi Ikeda, MD.

S-1 Radiation Coordinating Office Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital

masikeda@ncc.co.jp03-3542-2511

Outcome results

None listed

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