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

Phase 1
Conditions
Advanced squamous cell carcinoma of the esophagus which was deemed unresectable
Registration Number
JPRN-UMIN000010817
Lead Sponsor
Chiba University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
86
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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