Unique ID issued by UMIN | UMIN000010817 |
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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 |
The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial
The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial
The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial
The valproic acid combination chemotherapy for advanced squamous cell carcinoma of the esophagus phase 1/2 clinical trial
Japan |
Advanced squamous cell carcinoma of the esophagus which was deemed unresectable
Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Phase I,II
(phase 1) Frequency of dose limiting toxicity (DLT)
(phase 2) Response rate
(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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
valproic acid
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(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.
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.
86
1st name | |
Middle name | |
Last name | Hisahiro Matsubara |
Chiba University Hospital
Department of GI-Surgery
1-8-1, Inohana, Chuoku, Chiba
1st name | |
Middle name | |
Last name | Kentaro Murakami |
Chiba University Hospital
Clinical Research Center
1-8-1, Inohana, Chuoku, Chiba
Chiba University
None
Self funding
NO
2013 | Year | 05 | Month | 28 | Day |
Unpublished
Completed
2013 | Year | 01 | Month | 20 | Day |
2013 | Year | 02 | Month | 19 | Day |
2013 | Year | 03 | Month | 01 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 02 | Month | 28 | Day |
2013 | Year | 05 | Month | 28 | Day |
2019 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012666
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