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Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.

Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line. - Prospective observational study on the efficacy and safety of EPA in advanced gastric cancer patients treated by S-1+CDDP as first line.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016226
Enrollment
30
Registered
2015-01-15
Start date
2013-12-18
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

gastric cancer

Interventions

icosapentaenoic acid (EPA)

Sponsors

Kyushu medical center, medical oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients with clinically(radiographically/histologically/cytologically)proved adenocarcinoma of advanced gastric cancer and esophagogastric cancer (2)Patients who can intake orally (3)Patients without pretreatment for gastric cancer (4)Patients without previous chemotherapy for malignant tumor except for gastric cancer and radiation therapy to the abdominal legion (5)Patients with assessable lesion as defined by the Recist ver1.1 criteria (6)20-75 year-old at informedconsent (7)ECOG performance status(PS) 0-2 (8)Adequate bone marrow and organ function as defined as below -leukocyte count>=3000/mm3 -neutrophil count>=1500/mm3 -hemoglobin level>=8.0g/dL -platelet count>=100000/mm3 -AST and ALT=<100IU/L or AST and ALT=<200IU/L with liver metastases -total bilirubin=<1.5mg/dL -serum creatinin=<upper limit of average level in each facility, creatinin clearance>=50ml/min (10)Written informed consent obtained from patients

Exclusion criteria

Exclusion criteria: (1)Patients with active bleeding or beedingtendency (2)Patients who receive anticoagulant or antiplatelet drug (3)Patients without prior therapy with drugs or supplements contained icosapentaenoic acid (4)Patients with a history of allergy to icosapentaenoic acid (5)Patients scheduled for surgery (6)Patients scheduled for immune therapy (7)Patients with serious complication (8)Patients with immune-mediated illness (9)Patients with digestive symptom by ileus or gastrointestinal bleeding (10)Patients with symptomatic brain metastases or carcinomatous meningitis (11)Patients with massive pericardial effusion, pleural effusion or ascites *except for patients if effusions and ascites did not accumulate for more than two weeks after dranage therapy *include patients if pleurosclerosis was performed with anticancer drugs except OK-432 (12)Metachronous and synchronous double cancer (13)Bood tests positive for HBs antigen (14)Patients who receive continuous corticosteroid administration (15)Patients who receive drugs interact with S-1 or cisplatin (16)Uncontrolled psychiatry disease (17)Pregnant or lactating female and men who want to get partner pregnant (18)Judged inappropriate by the investigators

Design outcomes

Primary

MeasureTime frame
time to treatment failure(TTF) of a first-line chemotherapy

Secondary

MeasureTime frame
rate of weight loss, alteration in nutritional status, alteration in Glasgow Prognostic score, QOL(Quality of life), adverse events, progression free survival, response rete, relative dose intense, translational research

Countries

Japan

Contacts

Public ContactKotoe Takayoshi

Kyushu medical center medical oncology

t-kotoe@kyumed.jp092-852-0700

Outcome results

None listed

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