Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
|ClinicalTrials.gov Identifier: NCT00197444|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Squamous Cell Carcinoma||Drug: CDGP/5-FU combined with radiation Radiation: Radiotherapy||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2003|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2008|
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.
Other Names: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.
Other Name: Radiation
- Response rate [ Time Frame: 3 months ]
- Adverse events [ Time Frame: every 3-6 months ]
- Survival rate [ Time Frame: every 3-6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197444
|First Department of Medicine, Hamamatsu University School of Medicine|
|Hamamatsu, Japan, 431-3192|
|Principal Investigator:||Satoshi Osawa, M.D.||First Department of Medicine, Hamamatsu University School of Medicine|