UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009896
Receipt number 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 18:31:57

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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 or person

Institute

Chiba University

Institute

Department

Personal name



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

Value
https://center6.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