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A phase II clinical trial of neoadjyvant chemoradiation therapy using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer

A phase II clinical trial of neoadjyvant chemoradiation therapy using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer - Neoadjuvant chemoradiation therapy for locally advanced pancreatic cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010113
Enrollment
37
Registered
2013-03-01
Start date
2013-04-01
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

borderline resectable pancreatic cancer

Interventions

To investigate the frequency of histological curative resection following chemoradiation using Gemcitabine combined with IMRT for borderline resectable pancreatic cancer

Sponsors

Hepato-pamcreato-biliary Surgery and Transplantation, Graduate School of Medicine and Faculty of Medicine KyotoUniversity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with Histo-cytologically confirmed pancreatic cancer 2.Patients with radiologically defined patentially borderline resectable pancreatic cancer 3.Patients with Performance status of 0/1 4.Patients who have not undergone chemo and/or radiotherapyPatients with no metastatic disease confirmed by staging laparoscopy 5.Patiants who can oral intake 6.Patients with normal ECG findings 7.Patients with sustained organ function 8.Patients who received informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with lung fibrosis or interstitional pneumonia 2) Patients who can not underwent radiation therapy because of past radiation therapy 3) Severe co-morbid diseases 4) Intractable pleural and pericardical effusion, or ascites 5) Patients with other active cancers 6)Pregnancy or insufficient contraception 7) severe mental illness 8) Patients seems inadequate for this study by investigator(s)

Design outcomes

Primary

MeasureTime frame
Histological curative resection rate (R0 Ratio)

Secondary

MeasureTime frame
pathological responce rate, progression free survival, over all survival, incident of adverse event, mortality

Countries

Japan

Contacts

Public ContactMasaki Mizumoto

Graduate School of Medicine and Faculty of Medicine KyotoUniversity Hepato-pancreato-biliary Surgery and Transplantation

mizumoto@kuhp.kyoto-u.ac.jp075-751-4323

Outcome results

None listed

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