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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Squamous Cell Carcinoma
 Drug: CDGP/5-FU combined with radiation
Radiation: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chemoradiotherapy
 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

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197444

Locations
Japan
First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Investigators
Principal Investigator: Satoshi Osawa, M.D. First Department of Medicine, Hamamatsu University School of Medicine
  More Information

No publications provided by Hamamatsu University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Satoshi Osawa, M.D./Ph.D., First Department of Medicine, Hamamatsu University School of Medicine
ClinicalTrials.gov Identifier: NCT00197444     History of Changes
Other Study ID Numbers: HAMA-M1-C001
Study First Received: September 13, 2005
Last Updated: February 19, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hamamatsu University:
esophageal cancer
Nedaplatin
5-FU
 chemotherapy
radiation
chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Diseases
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Head and Neck Neoplasms
Fluorouracil
Nedaplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2012