Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 11:54 AM
Study NCT ID:
NCT00915850
Status:
UNKNOWN
Last Update Posted:
2010-09-09
First Post:
2009-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Sponsor:
Wakayama Medical University
Organization:
Study Overview
Official Title:
Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.
Detailed Description:
\<Phase I\>
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: