NCT00197444

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Hamamatsu University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-01-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2005-09-20
• Last updated: 2009-02-20

Locations

1 site across 1 country: Japan