Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197444
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
2005-09-13
Brief Title:
Low-Dose Nedaplatin CDGPCis-Diammine-Glycolatoplatinum5-FU Combined With Radiation for Esophageal Cancer
Sponsor:
Hamamatsu University
Organization:
Hamamatsu University
Study Overview
Official Title:
A Phase II Study of Daily Low-Dose of Nedaplatin CDGPCis-Diammine-Glycolatoplatinum and Continuous Infusion of 5-FU Combined With Radiation for the Treatment of Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
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:
The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin CDGP and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma
Detailed Description:
The tumor stages and disease grades were classified according to the TNM classification sixth edition of the International Union against Cancer UICC These were determined conventionally by computed tomography CT of the neck chest and abdomen bone scan endoscopic ultrasonography EUS endoscopy and esophagography
Low-dose of Nedaplatin CDGP 10 mgbodyday was daily administered on day 1-5 8-13 15-19 22-26 and 5-FU 500 mgbodyday was continuously administered on day 1-5 8-13 15-19 22-26 Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 18-20 Gy per fraction Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin
Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors UICC 2002 Toxicities were graded according to the Common Terminology Criteria for Adverse Events v30 CTCAE Survival was calculated from the start of chemoradiotherapy
Low-dose of Nedaplatin CDGP 10 mgbodyday was daily administered on day 1-5 8-13 15-19 22-26 and 5-FU 500 mgbodyday was continuously administered on day 1-5 8-13 15-19 22-26 Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 18-20 Gy per fraction Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin
Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors UICC 2002 Toxicities were graded according to the Common Terminology Criteria for Adverse Events v30 CTCAE Survival was calculated from the start of chemoradiotherapy
Study Oversight
Has Oversight DMC:
None
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?:
None