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

Hamamatsu University

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Carcinoma; Esophageal Cancer

Treatments: Radiation: Radiotherapy; Drug: CDGP/5-FU combined with radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00197444

HAMA-M1-C001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

1

Experimental group

Description:

Chemoradiotherapy

Treatment:

Drug: CDGP/5-FU combined with radiation

Radiation: Radiotherapy