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A Phase II trial of neoadjuvant therapy with GEM/IMRT for potentially resectable pancreatic cancer

A Phase II trial of neoadjuvant therapy with GEM/IMRT for potentially resectable pancreatic cancer - Neoadjuvant chemoradiation therapy for potentially resectable pancreatic cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022303
Enrollment
60
Registered
2016-06-07
Start date
2016-06-13
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

potentially resectable pancreatic cancer

Interventions

To investigate the overall survival rate following chemoradiation using Gemcitabine combined with IMRT for potentially resectable pancreatic cancer

Sponsors

Kyoto University
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
overall survival

Secondary

MeasureTime frame
disease-free survival, pathological responce rate, incident of adverse event, mortality

Countries

Japan

Contacts

Public ContactToshihiko Masui

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

tmasui@kuhp.kyoto-u.ac.jp075-751-3242

Outcome results

None listed

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