UMIN-CTR Clinical Trial

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
Last 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
1st 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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012666