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

Phase 2

Recruiting

• Conditions: Gastric cancer with peritoneal petastasis

• Registration Number: JPRN-jRCTs031180433
• Lead Sponsor: Yamaguchi Hironori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified