Exploratory study of adverse events in SOX+IP PTX for peritoenal metastasis of gastric cancer

JRCT ID: jRCTs031180433

Registered date:27/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer with peritoneal petastasis
• Date of first enrollment: 30/05/2017
• Target sample size: 15
• Study type: Interventional
• Intervention(s): S-1/Oxaliplatin plus intraperitoneal administration of PTX

Outcome(s)

• Primary Outcome: Kinds and frequency of adverse events
• Secondary Outcome: 1-year overall survival rate, response rate and negative conversion rate on peritoneal cytology

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Histologically or cytologically proven primary gastric adenocarcinoma
2) Peritoneal metastasis proven by imaging test or staging laparoscopy
3) Previously untreated with chemotherapy
4) Adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <1.5 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal), within 14 days before registration.
5) Eastern Cooperative Oncology Group performance status 0-2
6) Expected survival period of more than 3 months.
7) Age more than 20 years and less than 75 years
8) Adequate oral intake
9) Written informed consent

Exclude criteria

1) Metastasis to distant organ sites (such as the liver, lungs or bone)
2) Synchronous coexisting active cancer at registration
3) Palliative gastrectomy due to bleeding or stenosis
4) Massive uncontrolled ascites
5) Contraindication to S-1, paclitaxel or oxaliplatin
6) Serious concomitant heart disease or past history
7) Serious complication (intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes mellitus, renal failure or liver cirrhosis)
8) Pregnancy or intention to become pregnant
9) Judged inappropriate for this study for other reason

Related Information

• Primary Sponsor: Yamaguchi Hironori
• Secondary ID(s): UMIN000025501