Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
Overview
- Phase
- Phase 3
- Intervention
- radiation
- Conditions
- Cervical Cancers
- Sponsor
- Korea Cancer Center Hospital
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- compliance
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Sang-Young Ryu
Chair of Cerivcal/Ovarian Cancer Center
Korea Cancer Center Hospital
Eligibility Criteria
Inclusion Criteria
- •Histologically proven cervical cancer
- •Squamous, Adenosquamous, Adeno carcinoma cell type
- •International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
- •Gynecologic Oncology Group (GOG) performance status 0 - 2
Exclusion Criteria
- •Previous history of chemotherapy or radiation
- •History of other cancer
- •Hypersensitivity to platinum agents
- •Pregnancy
- •Serious medical disease
Arms & Interventions
weekly cisplatin
Weekly cisplatin 40mg/m2 during radiation therapy
Intervention: radiation
weekly cisplatin
Weekly cisplatin 40mg/m2 during radiation therapy
Intervention: weekly cisplatin
tri-weekly cisplatin
cisplatin 75mg/m2 three cycles, every 3 weeks
Intervention: radiation
tri-weekly cisplatin
cisplatin 75mg/m2 three cycles, every 3 weeks
Intervention: tri-weekly cisplatin
Outcomes
Primary Outcomes
compliance
Time Frame: 3 month
1. Percentage of completed cycles of scheduled chemotherapy in each arm 2. Percentage of grade III and IV toxicity 3. Delayed radiation time due to toxicity
Secondary Outcomes
- survival(5 years)