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

Phase 2

Completed

• Conditions: Esophageal Cancer; Squamous Cell Carcinoma
• Interventions: Drug: CDGP/5-FU combined with radiation; Radiation: Radiotherapy

• Registration Number: NCT00197444
• Lead Sponsor: Hamamatsu University

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-19
• Last Update Posted: 2009-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CDGP/5-FU combined with radiation	Chemoradiotherapy
1	Radiotherapy	Chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Response rate	3 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	every 3-6 months
Survival rate	every 3-6 months

Trial Locations

Locations (1)

First Department of Medicine, Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Japan