UMIN-CTR Clinical Trial

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

Esophageal cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chiba University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

01

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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