Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
NCT ID: NCT00197444
Last Updated: 2009-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2003-01-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Chemoradiotherapy
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* prior chemotherapy and radiotherapy
20 Years
85 Years
ALL
No
Sponsors
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Hamamatsu University
OTHER
Responsible Party
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First Department of Medicine, Hamamatsu University School of Medicine
Principal Investigators
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Satoshi Osawa, M.D.
Role: PRINCIPAL_INVESTIGATOR
First Department of Medicine, Hamamatsu University School of Medicine
Locations
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First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu, , Japan
Countries
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References
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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.
Other Identifiers
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HAMA-M1-C001
Identifier Type: -
Identifier Source: org_study_id
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