NCT01097252

Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Korea Cancer Center Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.

Detailed description

This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.

Conditions

• Cervical Cancers

Interventions

Type	Name	Description
RADIATION	radiation	radiation with cisplatin 40mg/m2, 6 cycles, every week
DRUG	weekly cisplatin	weekly cisplatin 40mg/m2, 6 cycles
DRUG	tri-weekly cisplatin	cisplatin 75mg/m2, 3cycles, every 3 weeks

Timeline

• Start date: 2002-01-01
• Primary completion: 2004-12-01
• Completion: 2009-12-01
• First posted: 2010-04-01
• Last updated: 2014-05-09

Locations

1 site across 1 country: South Korea