UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Hyperthermia with chemotherapy for peritoneal metastastic gastric cancer (GCDS-EHY2000 PI/II)
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary objective of the study is to examine 1 year overall survival of the treatment (docetaxel, S-1 and Oncothermia) in subjects with peritoneal metastatic gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	To examine one year overall survival
Key secondary outcomes	Negative conversion rate of washing cytology of peritoneal cavity, CR rate of peritoneal metastasis, overall survival, progression free survival, response rate, the rate of conversion therapy, the rate of radical surgery, rate of adverse effects.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Docetaxel: 40 mg/m2 (1 hour IV infusion) on Day 1 of each cycle S-1: target dose of 80 mg/m2/day (orally) on Days 1 through 14 of each cycle (actual dose dependent upon BSA). Oncothermia for 1 hour on 2 times each weak.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma. 2.Cancer cell is proved by cytology for abdominal cavity by an operation, laparoscopy or abdominal tap within 28 days before registration. It is desirable for the biopsy of the peritoneum nodule. 3.Oral intake is possible or to perform nutritional management in enteral nutrition or total parenteral nutrition at home. 4.Age 20-79 years. 5.ECOG performance status 0 or 1. 6.Life expectancy estimated more than 3 months. 7.Bone marrow, liver, renal function by measurement data within 14th before registration. 1)Hgb>8.0 g/dL 2)WBC 3000-12,000/mm3 3)platelets> 70,000/mm3 4)Total bilirubin< 1.5 X UNL 5)AST (SGOT) and ALT (SGPT)< 100 IU/L 6)Creatinine: Lower than upper limit of the standard value 8)Written informed consent
Key exclusion criteria	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.
Target sample size	33

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Chiba University
Division name	Frontier Surgery
Address	1-8-1 Inohana, Chuo-Ku, Chiba City, Japan
TEL	043-226-2110
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	Masayuki Kano
Organization	Chiba University
Division name	Frontier Surgery
Address	1-8-1 Inohana, Chuo-Ku, Chiba City, Japan
TEL	043-226-2110
Homepage URL
Email	mkano@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Frontier Surgery, Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 23 Day
Last modified on	2017 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025842