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Completed

NCT Number: NCT00197444

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

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First Department of Medicine, Hamamatsu University School of Medicine

Hamamatsu, 431-3192, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDGP/5-FU combined with radiation

Drug

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

Radiotherapy

Radiation

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 names: Radiation

Primary outcomes

  1. Response rate

    Time frame: 3 months

Secondary outcomes

  1. Adverse events

    Time frame: every 3-6 months

  2. Survival rate

    Time frame: every 3-6 months

Sponsors and collaborators

Lead sponsor

Hamamatsu University

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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