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Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment

Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment - Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027633
Enrollment
56
Registered
2017-07-01
Start date
2017-07-01
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

resectable pancreatic cancer with less than 180 degree portal vein abutment

Interventions

Neoadjuvant chemotherapy group S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks. Radiotherapy: 1.8 Gy/day, 28days, a total of

Sponsors

Nagoya University, Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with pancreatic cancer (2) Patients without distant metastasis, M0 (UICC8th TNM) (3) Resectable pancreatic cancer by NCCN guideline (Version 2. 2016) with less than180 degree portal vein abutment and without encasement (4) ECOG PS 0-1 (5) No prior therapy for pancreatic cancer (6) Patients without active cancer of other organs (7) Patients who can intake orally (8) Main organs function test almost within normal range (9) Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation

Exclusion criteria

Exclusion criteria: (1) Patients who have allergies to S-1 (2) Patients who have active infection (3) Patients with active peptic ulcer (4) Patients with ileus (5) Patients with Grade>=2 diarrhea according to CTCAE v4.0 (6) Patients with uncontrolled ascites or pleural effusion (7) Patients with flucytosine, phenytoin, or warfarin potassium administration (8) Patients with serious comorbid conditions (9) Patients with pregnancy (10) Patients with serious psychiatric diseases (11) Patients who were deemed inappropriate for medical reasons

Design outcomes

Primary

MeasureTime frame
Local recurrence rate within 2 years after surgery

Countries

Japan

Contacts

Public ContactSuguru Yamada

Nagoya University, Graduate School of Medicine Gastroenterorogical Surgery

suguru@med.nagoya-u.ac.jp052-744-2253

Outcome results

None listed

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