UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010817
Receipt number R000012666
Scientific Title The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial
Date of disclosure of the study information 2013/05/28
Last modified on 2019/03/29 14:18:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial

Acronym

The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial

Scientific Title

The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial

Scientific Title:Acronym

The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial

Region

Japan


Condition

Condition

Advanced squamous cell carcinoma of the esophagus which was deemed unresectable

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate the safety and efficacy of chemotherapy with a combination of valproic acid and 5-FU / cisplatin therapy for advanced squamous cell carcinoma of the esophagus which was deemed unresectable.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

(phase 1) Frequency of dose limiting toxicity (DLT)
(phase 2) Response rate

Key secondary outcomes

(phase 1)
Adverse event, Response rate, Blood concentration of valproic acid, Histone modifications in peripheral blood mononuclear cells (PBMC)
(phase 2)
Overall survival, Progression free survival, The ratio of the patients who completed the course, Blood concentration of valproic acid, Histone modifications in peripheral blood mononuclear cells (PBMC)


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

Medicine

Interventions/Control_1

valproic acid

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Esophageal cancer, which has been demonstrated to be a squamous cell carcinoma tissue type by the endoscopic biopsy.
(2) In the time of registration, advanced or recurrent squamous cell carcinoma of the esophagus which was deemed unresectable.
(3) Age at the time of obtaining informed consent should be over 20 years old and less than 75 years.
(4) Performance Status (ECOG) should be 0 or 1.
(5) Measurable lesion according to RECIST ver 1.1 is found at least one.
(6) Oral intake is possible.
(7) Bone marrow, liver and renal function should have the following measured data within 14 days prior to registration.
1) white blood cell count: More than 4,000 /mm3
2) neutrophil count: More than 2,000 /mm3
3) hemoglobin: More than 8.0g/dL
4) platelet count: More than 10x104/mm3
5) total bilirubin: Less than 1.5 mg/dL
6) AST (GOT): less than 150 U/L
7) AST (GOT): less than 150 U/L
8) serum creatinine: less than 1.2mg/dL
9) 24-hour creatinine clearance: More than 60ml/min
(8) Consent in writing has been obtained from patients for participation in this study.

Key exclusion criteria

1) 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)
2) Patients with esophageal primary tumor forming a fistula.
3) Patients undergone chemotherapy as the prior treatment. FP therapy until 2 course as the adjuvant chemotherapy is not included.
4) Patients undergone chemotherapy within 6 months of the date of registration.
5) Patients suffering from infection requiring systemic treatment.
6) Patients admitted fever over 38 degree.
7) Women with (making) the possibility of pregnancy and pregnant or lactating women.
8) Patients with mental disorders are thought to require treatment or during treatment with antipsychotic drugs.
9) The oral or injectable steroids are under use.
10) Patients with the uncontrolled diabetes.
11) Patients with the uncontrolled hypertension.
12) Patients with the unstable angina or myocardial infarction within 6 months.
13) Patients who have a history of viral hepatitis with HBs antibody or HCV antibody-positive.
14) Patients with HIV antibody-posotive.
15) Patients with the chronic lung disease (interstitial pneumonia, pulmonary fibrosis, advanced emphysema).
16) Cases the physician (sharing) was deemed inappropriate as the subject of the study investigator.

Target sample size

86


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


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Murakami

Organization

Chiba University Hospital

Division name

Clinical Research Center

Zip code


Address

1-8-1, Inohana, Chuoku, Chiba

TEL


Homepage URL


Email



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 05 Month 28 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

2013 Year 01 Month 20 Day

Date of IRB

2013 Year 02 Month 19 Day

Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry

2019 Year 02 Month 28 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 28 Day

Last modified on

2019 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012666


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name