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

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ClinicalTrials.gov Identifier: NCT00197444
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 20, 2009
Sponsor:
Information provided by:

Study Description
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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2003
Primary Completion Date : September 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Response rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: every 3-6 months ]
  2. Survival rate [ Time Frame: every 3-6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

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

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