Skip to content

Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer

Phase I study of preoperative chemo-radiotherapy with alternate-day administrations of S-1 and radiation in patients with pancreatic cancer - Phase I study of preoperative chemo-radiotherapy in patients with pancreatic cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003795
Enrollment
12
Registered
2010-06-22
Start date
2010-05-01
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

preoperative chemoradiotherapy with 1 course of S-1 preoperative chemoradiotherapy with 2course of S-1

Sponsors

Wakayama Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Confirmed boarder-line resectable pancreatic cancer as adenocarcinoma by histological, cytological, or radiological examinations 2)Confirmed target region 3)No prior treatment 4)Age 20-80 5)PS 0/1 6)Adequate organ functions neutrophils >=1,500/mm3 leukocytes >=4,000/mm3, =<12,000/mm3 platelets >=100,000/mm3 hemoglobin >=10.0g/dL AST(GOT)/ALT(GPT)/ALP within 3 times of normal limits total bilirubin <=1.5mg/dL BUN <= 25mg/dl serum creatinine <=1.5mg/dL creatinine clearance >=50mL/min 6)PS(ECOG) 0-2 7)Sufficient oral intake 8)With written informed consent 9)Estimated life expectancy of at least 3 months

Exclusion criteria

Exclusion criteria: 1)Active double cancer 2)Severe diarrhea 3)Symptomatic pulmonary fibrosis or interstitial pneumonia. Marked pleural or peritoneal effusion 4)Metastasis in central nervous system 5)para-aortic lymph node metastasis 6)Severe complications, such as ileus, heart failure and renal failure 7)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 8)History of severe anaphylaxies 9)Active infection 10)Severe mental disorder 11)Patients under treatment with flucytosine, phenytoin or warfarin potassium 12)Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

MeasureTime frame
Safety,Efficacy

Countries

Japan

Contacts

Public ContactMasaji Tani

Wakayama Medical University, School of Medicine Second Department of Surgery

srg2@wakayama-med.ac.jp073-447-2300

Outcome results

None listed

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