Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer

This study has been completed.

Sponsor:

Information provided by:

Hamamatsu University

ClinicalTrials.gov Identifier:

NCT00197444

First received: September 13, 2005

Last updated: February 19, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 19, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

all cause mortality at one year

Change History

Complete list of historical versions of study NCT00197444 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
Survival rate [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

adverse events
progression free survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer

Official Title ^ICMJE

A Phase II Study of Daily Low-Dose of Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum) and Continuous Infusion of 5-FU Combined With Radiation for the Treatment of Esophageal Cancer

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 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day 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 1.8-2.0 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 v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Esophageal Cancer
Squamous Cell Carcinoma

Intervention ^ICMJE

Drug: CDGP/5-FU combined with radiation
Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.
Other Names:
- Nedaplatin
- 5-FU
Radiation: Radiotherapy
Fractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction.

Other Name: Radiation

Study Arm (s)

Experimental: 1

Chemoradiotherapy

Interventions:

Drug: CDGP/5-FU combined with radiation
Radiation: Radiotherapy

Publications *

Osawa S, Furuta T, Sugimoto K, Kosugi T, Terai T, Yamade M, Takayanagi Y, Nishino M, Hamaya Y, Kodaira C, Yamada T, Iwaizumi M, Takagaki K, Yoshida K, Kanaoka S, Ikuma M. Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma. BMC Cancer. 2009 Nov 22;9:408.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

newly diagnosed cases histologically as squamous cell carcinoma,
a performance status 0 to 2,
white blood cells >3,000/microL,
platelets >100,000/microL,
serum total bilirubin <2.0 mg/dl,
serum transaminase <3 times the upper normal limit,
serum creatinine <1.5 mg/dl,
creatinine clearance >60 ml/min

Exclusion Criteria:

serious cardiac disease
prior chemotherapy and radiotherapy

Gender

Both

Ages

20 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00197444

Other Study ID Numbers ^ICMJE

HAMA-M1-C001

Has Data Monitoring Committee

Yes

Responsible Party

Satoshi Osawa, M.D./Ph.D., First Department of Medicine, Hamamatsu University School of Medicine

Study Sponsor ^ICMJE

Hamamatsu University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Satoshi Osawa, M.D.

First Department of Medicine, Hamamatsu University School of Medicine

Information Provided By

Hamamatsu University

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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