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

This study has been completed.
Sponsor:
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00197444
First received: September 13, 2005
Last updated: February 19, 2009
Last verified: February 2009

September 13, 2005
February 19, 2009
January 2003
September 2008   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
all cause mortality at one year
Complete list of historical versions of study NCT00197444 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: every 3-6 months ] [ Designated as safety issue: Yes ]
  • Survival rate [ Time Frame: every 3-6 months ] [ Designated as safety issue: No ]
  • adverse events
  • progression free survival
Not Provided
Not Provided
 
Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
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 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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Squamous Cell Carcinoma
  • 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:
    • Nedaplatin
    • 5-FU
  • 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
Experimental: 1
Chemoradiotherapy
Interventions:
  • Drug: CDGP/5-FU combined with radiation
  • Radiation: Radiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00197444
HAMA-M1-C001
Yes
Satoshi Osawa, M.D./Ph.D., First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu University
Not Provided
Principal Investigator: Satoshi Osawa, M.D. First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP