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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


Phase 2
20 Years
85 Years
Not Enrolling
Both
Esophageal Cancer, Squamous Cell Carcinoma

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Satoshi Osawa, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

First Department of Medicine, Hamamatsu University School of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

HAMA-M1-C001

NCT ID:

NCT00197444

Start Date:

January 2003

Completion Date:

December 2008

Related Keywords:

  • Esophageal Cancer
  • Squamous Cell Carcinoma
  • esophageal cancer
  • Nedaplatin
  • 5-FU
  • chemotherapy
  • radiation
  • chemoradiotherapy
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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