DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Hamamatsu University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer; Squamous Cell Carcinoma

Intervention: CDGP/5-FU combined with radiation (Drug); Radiotherapy (Radiation)

Phase: Phase 2

Status: Completed

Sponsored by: Hamamatsu University

Official(s) and/or principal investigator(s):
Satoshi Osawa, M.D., Principal Investigator, Affiliation: First Department of Medicine, Hamamatsu University School of Medicine


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.

Clinical Details

Official title: 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

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

Primary outcome: Response rate

Secondary outcome:

Adverse events

Survival rate

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.


Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.


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

Locations and Contacts

First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3192, Japan
Additional Information

Starting date: January 2003
Last updated: February 19, 2009

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017