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Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study

Neoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study - HOPS-R01

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013031
Enrollment
50
Registered
2014-01-31
Start date
2013-11-01
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

pancreatic cancer

Interventions

S-1:80mg/day(BSA&lt
1.5/m2), day1-28. 1 cycle 6weeks, repeat 2 cycles before surgery

Sponsors

Hokkaido Pancreatic Cancer Study Group (HOPS)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically or cytologically proven diagnosis of pancreas cancer. 2) Definition of a Resectable pancreatic cancer is filled in NCCN guidelines 2012 pancreatic adenocarcinoma 3) Without distant metastasis 4) Patients of age =>20 5) Performance Status:0-1 (ECOG) 6) Adequate oral intake 7) Good main organ function 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Treatment history of S-1 2) Treatment history of a pancreatic cancer 3) Regular use of frucitocin, fenitoin or warfarin 4) Patients who can' t receive neither iodic drug because of drug allergy 5) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings 6) Massive pleural or abdominal effusion 7) Severe infection 8) Watery diarrhea 9) Uncontrolled diabetes 10) Simultaneous or metachronous (within 3 years) double cancers 11) Hemorrhagic peptic ulcer 12) Patients with severe disease 13) Patients requiring systemic steroids medication 14) Severe mental illness 15) Severe drug hypersensitivity 16)Pregnant females, possibly pregnant females, females wishing to become pregnant or Males that are currently attempting to produce a pregnancy 17)Patients seems inadequate for this study by investigators

Design outcomes

Primary

MeasureTime frame
Two year progression free survival

Secondary

MeasureTime frame
Two year overall survival, Resection rate, Pathological effect, Response rate, Adverse effect, Surgical complication

Countries

Japan

Contacts

Public ContactToru Nakamura

Hokkaido University Gastroenterological Surgery II

torunakamura@med.hokudai.ac.jp011-706-7714

Outcome results

None listed

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