Esophageal Cancer, Squamous Cell Carcinoma
Conditions
Keywords
esophageal cancer, Nedaplatin, 5-FU, chemotherapy, radiation, chemoradiotherapy
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.
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.
Interventions
DRUGCDGP/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.
RADIATIONRadiotherapy
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.
Sponsors
Hamamatsu University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | every 3-6 months |
| Survival rate | every 3-6 months |
Countries
Japan
Outcome results
None listed