UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022420 |
|---|---|
| Receipt number | R000025842 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2017/11/27 17:44:44 |
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Basic information
Public title
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
Acronym
Hyperthermia with chemotherapy for peritoneal metastastic gastric cancer (GCDS-EHY2000 PI/II)
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Chiba University
Division name
Frontier Surgery
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba City, Japan
TEL
043-226-2110
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kano |
Organization
Chiba University
Division name
Frontier Surgery
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba City, Japan
TEL
043-226-2110
Homepage URL
mkano@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025842
