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Low-Dose CDGP/5-FU Combined With Radiation for Esophageal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

20 to 85

Other

HAMA-M1-C001
NCT00197444

Trial Description

Summary

The purpose of this study is to clarify efficacy and toxicity of low-dose Nedaplatin (CDGP) / 5-FU combined with radiation in patients with esophageal cancer.

Further Study Information

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.

The World Health Organization criteria were used to determine the tumor response. Toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.

Eligibility Criteria

Inclusion Criteria:

newly diagnosed cases histologically as squamous cell carcinoma,

a performance status less than 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Hamamatsu University School of Medicine

Satoshi Osawa, M.D.

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00197444
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.