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

NCT00197444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2009-02-20

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Hamamatsu University

    lead OTHER

Principal Investigators

  • Satoshi Osawa, M.D. · First Department of Medicine, Hamamatsu University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2008-09-30
Completion
2008-12-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00197444 on ClinicalTrials.gov