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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
radiation with cisplatin 40mg/m2, 6 cycles, every week
weekly cisplatin 40mg/m2, 6 cycles
cisplatin 75mg/m2, 3cycles, every 3 weeks
Korea Institute of Radiological & Medical Sciences
Seoul, South Korea
compliance
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
Time frame: 3 month
survival
1. 5 year progression free survival 2. 5 year survival rate
Time frame: 5 years
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