Clinical trial NCT00197444: Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Squamous Cell Carcinoma
Keywords: esophageal cancer
Nedaplatin
5-FU
chemotherapy
radiation
chemoradiotherapy
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: every 3-6 months
measure: Survival rate
timeFrame: every 3-6 months
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: First Department of Medicine, Hamamatsu University School of Medicine
Study officials:
affiliation: First Department of Medicine, Hamamatsu University School of Medicine
name: Satoshi Osawa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osawa S, Furuta T, Sugimoto K, Kosugi T, Terai T, Yamade M, Takayanagi Y, Nishino M, Hamaya Y, Kodaira C, Yamada T, Iwaizumi M, Takagaki K, Yoshida K, Kanaoka S, Ikuma M. Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma. BMC Cancer. 2009 Nov 22;9:408. doi: 10.1186/1471-2407-9-408.