A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer (CCOG-1001)

A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer (CCOG-1001) - A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003768

Enrollment

Registered

2010-06-17

Start date

2010-06-01

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

resectable pancreatic cancer

Interventions

Adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) invasive ductal carcinoma of the pancreas 2) resectable (R0/1) stage III or IV pancreatic cancer (classification of Japan Pancreas Society) 3) no prior therapy except pancreatectomy 4) ECOG PS: 0-1 5) sufficient organ functions within a week before surgery WBC > 4000/mm3, < 12000/mm3 Neutrophil > 2000/mm3 Plt > 100000/mm3 Hb > 9.5g/dl T-Bil < 2.0mg/dl AST,ALT < 150 IU/L Creatinine clearance > 60mL/min 6) no liver damage, Child-Pugh Grade A 7) no abnormal electrocardiogram 8) enable to oral intake 9) written informed consent

Exclusion criteria

Exclusion criteria: 1) serious intra- or postoperative complications 2) regular use of fenitoin, warfarin or frucitocin 3) systemic administration of other fluorouracil 4) intractable watery diarrhea 5) severe psychological disease 6) active infection 7) serious complications (bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus, heart failure, renal failure, active peptic ulcer, deep venous thrombosis and so on) 8) serious myelosuppression 9) interstitial pneumonia or pulmonary fibrosis 10) radiotherapy to the chest 11) pleural effusion or ascites 12) active malignancy in other organ 13) allergic reaction for gemcitabine or S-1 14) chronic liver damage 15) impossible insertion of the catheter to the portal vein 16) pregnant or breast feeding 17) Patients judged inappropriate for the study by the physicians

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
disease free survival, adverse effect, proportion of treatment completion, relative dose intensity, rate of liver metastasis	—

Countries

Japan

Contacts

Public ContactTsutomu Fujii

Nagoya University Graduate School of Medicine Department of Surgery II (Gastroenterological surgery)

fjt@med.nagoya-u.ac.jp

Outcome results

None listed

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