Advanced squamous cell carcinoma of the esophagus which was deemed unresectable
Conditions
Interventions
valproic acid
Sponsors
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (phase 1) Frequency of dose limiting toxicity (DLT) (phase 2) Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (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) | — |
Countries
Japan
Contacts
Public ContactKentaro Murakami
Chiba University Hospital Clinical Research Center
Outcome results
None listed