Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
NCT ID: NCT00915850
Last Updated: 2010-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2007-08-31
2015-08-31
Brief Summary
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Detailed Description
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Primary Objective:
To establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objective:
To observe the efficacy of this regimen in these patients.
\<Phase II\>
Primary Objective:
To assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objectives:
To determine the adverse reactions of this regimen in these patients. To determine TTP(Time to progression) of patients treated with this regimen. To determine MST(Median survival time) of patients treated with this regimen.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anticancer drug
docetaxel, cisplatin and 5-FU
DCF
docetaxel, Cisplatin and 5-FU
Interventions
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DCF
docetaxel, Cisplatin and 5-FU
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-1
* 20 years and older
* Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor
* Tissue from tumor must be available
* Patients must have measurable disease
* Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month
* Life expectancy \> 3 months
* Laboratory values as follows
* 3000/mm3 \< WBC \< 12000/mm3
* 1500/mm3 \< granulocyte count
* 8.0 gm/dl \< hemoglobin
* Platelet count \> 100000/mm3
* Aspartate transaminase \< 150 IU/L
* Alanine transaminase \< 150 IU/L
* Creatinine \< 1.5 mg/dl
* Able and willing to give valid written informed consent
Exclusion Criteria
* Active or uncontrolled infection
* Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week
* Clinically significant heart disease
* Patients with a history of myocardial infarction within the previous three months
* Patients with uncontrolled diabetes mellitus or hypertension
* Presence of clinically apparent central nervous system metastases
* Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
* Decision of unsuitableness by principal investigator or physician-in-charge
20 Years
ALL
No
Sponsors
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Wakayama Medical University
OTHER
Responsible Party
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Wakayama Medical University
Principal Investigators
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Makoto Iwahashi, M.D.
Role: STUDY_DIRECTOR
Second Department of Surgery, Wakayama Medical University
Locations
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Wakayama Medical University
Wakayama, Wakayama, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WMU-EC01
Identifier Type: -
Identifier Source: org_study_id