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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009896
Receipt No. R000011594
Scientific Title Phase I / II study of EHY2000 oncothermia therapy for advanced esophageal cancer
Date of disclosure of the study information 2013/01/29
Last modified on 2015/11/16

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Basic information
Public title Phase I / II study of EHY2000 oncothermia therapy for advanced esophageal cancer
Acronym Phase I / II study of EHY2000 oncothermia therapy for advanced esophageal cancer
Scientific Title Phase I / II study of EHY2000 oncothermia therapy for advanced esophageal cancer
Scientific Title:Acronym Phase I / II study of EHY2000 oncothermia therapy for advanced esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study treats unresectable or recurrent esophageal squamous cell carcinoma which is no more treated by standard therapy. We apply heat therapy by using EHY-2000 from body surface, not invasively, and we evaluate adverse reactions and safety, antitumor effect, and immune response, and thus we investigate usefulness of this new thermal treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I: Evaluation of safety and dverse reactions
Phase II: Immune response and anti-tumor effects
Key secondary outcomes Phase I: QOL
Phase II: QOL, OS, PFS

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Hyperthermia EHY2000
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) Recurrent esophageal cancer progression which has been demonstrated to be a squamous cell carcinoma tissue type.

(2) Prolongation of survival cannot be expected by conventional surgery, chemotherapy, radiation therapy which are covered by health insurance.

(3) Measurable lesion according to RECIST ver 1.1 is found at least one.

(4) Age at the time of obtaining informed consent should be over 20 years old and less than 80 years, irrespective of gender.

(5) Performance Status (ECOG) should be 0 or 1.

(6) In the time of registration 4 weeks should have elapsed since when the prior treatment (surgery, chemotherapy or radiation therapy) was done.

(7) Prognosis is expected to be more than two months from the date of registration.

(8) Bone marrow, liver and renal function should have the following measured data within 14 days prior to registration.
1) hemoglobin: More than 8.0g/dL
2) white blood cell count: Less than 2,000 ~ 12,000/mm3
3) platelet count: More than 7x104/mm3
4) total bilirubin: Less than 1.5 mg/dL
5) AST (GOT); ALT (GPT): less than 100 U/L
6) serum creatinine: Below the upper limit of the reference values
7) O2Sat: More than 92%
** Even if the value of AST (GOT), ALT of (GPT) does not meet the above conditions, it is caused by the underlying disease is left to the discretion of the physician investigator or trial division has priority if it be judged to be caused by the underlying disease.

(9) Consent in writing has been obtained from patients for participation in this study.
Key exclusion criteria (1) patients having history of hyperthermia therapy.

(2) Patients with esophageal primary tumor forming a fistula.

(3) Patients admitted fever with obvious infection (over 38.5 degree)

(4) Seriously malnutrition

(5) With pleural effusion, ascites, and pericardial which requires control

(6) Heart disease (requiring hospitalization) or severe cases with a history

(7) Other complications cases that require hospitalization (intestinal paralysis, intestinal obstruction, pulmonary fibrosis, diabetes control is difficult, renal failure, or cirrhosis of the liver, such as interstitial pneumonia)

(8) (Patients with mental disorders are thought to require treatment or during treatment with antipsychotic drugs.

(9) At the time of registration those who has cancers concurrency or has a metachronous cancers with disease-free interval less than 5 years (carcinoma in situ lesions and carcinoma in situ that are considered cured by local treatment is not included)

(10) The oral or injectable steroids is under use

(11) Antigen HBs, antibody HCV, HTLV-1 antibody-positive or have a history of hepatitis or HIV antibodies.

(12) With a history of hypersensitivity to albumin.

(13) Women with (making) the possibility of pregnancy and pregnant or lactating women.

(14) Men who have intention to make pregnant.

(15) Patients with autoimmune disease.

(16) Cases the physician (sharing) was deemed inappropriate as the subject of the study investigator.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Chiba University Hospital
Division name Department of GI-Surgery
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba
TEL 043-226-2110
Email matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Akutsu
Organization Chiba University
Division name Department of Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba
TEL 043-226-2110
Homepage URL
Email yakutsu@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization None
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
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 29 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 Completed
Date of protocol fixation
2012 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 29 Day
Last modified on
2015 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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