Phase I/II Trial of a novel mild hyperthermia using Oncothermia (EHY-2000) and TS-1/Docetaxel in the treatment of peritoneal metastatic gastric cancer - Hyperthermia with chemotherapy for peritoneal metastastic gastric cancer (GCDS-EHY2000 PI/II)

Chiba University0 sites33 target enrollmentMay 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

May 23, 2016

End Date

March 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Active double cancer 2\. S\-1 contraindication 3\. to take flucytosine, phenytoin and warfarin potassium 4\. History of hypersensitivity to fluoropyrimidines, docetaxel, or medications formulated with polysorbate 80, other severe drug induced allergy 5\. Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, uncontrolled hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.). 6\. to suffer active infections or acute inflammatory diseases 7\. Patient with positive HBs antigen or positive HCV antibody 8\. Patient with severe diarrhea 9\. 10Pregnancy or lactation women, women with suspected pregnancy or men with willing to get pregnant. 11\. Patient with psychosis or psychotic symptoms and judged to be difficult to determine participating clinical trial. 12\. Patient with edema not to control with oral diuretics 13\. patient with peripheral neuropathy more than Grade 3\. 14\. Positive for HIV antibody. 15\.16 Patient with severe pleural or pericardial effusion and ascites impossible to control. 17\. Definite contraindications for the use of corticosteroids. 18\. patient with autoimmune diseases. 19\. patient with more important non\-curative factors rather than peritoneal metastasis. 20\. Any subject judged by the investigator to be unfit for any reason to participate in the study.