Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)

Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001) - Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003658

Enrollment

Registered

2010-05-24

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

Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression. In addition, an EPA-enriched oral supplement was

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as pancreatic cancer 2. Recurrent or unresectable pancreatic cancer 3. Histologically proven invasive tubular adenocarcinoma, or adenosquamous carcinoma for pancreatic cancer 4. Without CNS metastasis 5. ECOG PS of 0, 1 or 2 6. Sufficient oral intake 7. Aged over 20 years old 8. Adequate organ functions 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. With moderate or more ascites/pleural effusion 2. Plumonary fibrosis or interstitial pneumonia 3. Cardiac insufficiency or myocardial infarction within six months 4. Active bacterial or fungous infection 5. Uncontrollable diabetes mellitus 6. Psychosis or severe mental disorder 7. Severe drug allergy 8. Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy 9. Previous chemotherapy or radiotherapy against any other malignancies within 3 years 10. Gemcitabine chemotherapy but with the permission over 6 months after adjuvant chemotherapy 11. Previous therapy against pancreatic cancer 12. With CNS metastasis 13. Pregnant, lactating women or women of childbearing potential 14. Men who want to get partner pregnant 15. Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
overall survival (1-year survival)	—

Secondary

Measure	Time frame
progression-free survival, response rate, adverse events, severe, QOL evaluation, body weight, performance status.	—

Countries

Japan

Contacts

Public ContactMakoto Ueno

YCOG001 Coordinating Office Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center

kantansui@kcch.jp045-391-5761

Outcome results

None listed

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