A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01)

A phase II study of adjuvant chemotherapy with 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine for patients with resected pancreatic cancer (TOSPAC-01) - A phase II study of portal infusion chemotherapy followed by gemcitabine for resected pancreatic cancer (TOSPAC-01)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004504

Enrollment

Registered

2010-11-15

Start date

2010-11-01

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

Resected pancreatic cancer

Interventions

With adjuvant chemotherapy of 5-FU and heparin-based portal infusion chemotherapy followed by gemcitabine after surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven invasive ductal carcinoma of the pancreas 2) Macroscopically curative resection (R0, R1) 3) No history of prior chemotherapy or radiotherapy for pancreatic cancer except pancreatectomy 4) ECOG PS: 0-1 5) Sufficient organ functions before surgery WBC > 4,000/mm3 Neutrophil > 2,000/mm3 Plt > 100,000/mm3 Hb > 9 g/dl AST, ALT < 5 times the upper limit of the normal range Serum creatinine < the upper limit of the normal range 6) Placement of the catheter for portal infusion chemotherapy within the portal vein 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Pulmonary fibrosis or interstitial pneumonia 2) Uncontrolled pleural effusion 3) Resection of the distant organ metastasis 4) Active double cancer 5) Active infection 6) History of serious complications related to surgery 7) Active peptic ulcer 8) History of myocardial infarction within three months 9) Severe mental disorder 10) Pregnant or breast feeding 11) Patients judged inappropriate for the study by the physicians

Design outcomes

Primary

Measure	Time frame
Disease free survival Incidence of severe adverse events	—

Secondary

Measure	Time frame
Overall survival Incidence of adverse events Proportion of treatment completion	—

Countries

Japan

Contacts

Public ContactMinoru Kitago

Keio University School of Medicine Department of Surgery

contact@keio-hpbts.jp03-3353-1211

Outcome results

None listed

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