NCT01175460

S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.

Detailed description

Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer. Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	S-1, Nedaplatin	nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 on Days 1-14, repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-08-04
• Last updated: 2012-03-06

Locations

1 site across 1 country: China