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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Satoshi Osawa, M.D.
First Department of Medicine, Hamamatsu University School of Medicine
Japan: Ministry of Health, Labor and Welfare