A Phase 3 interventional study of radiation and weekly cisplatin in Cervical Cancers, sponsored by Korea Cancer Center Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-05-09.
Sponsored by Korea Cancer Center Hospital · Phase 3, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 104 is close to the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Korea Cancer Center Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Weekly cisplatin 40mg/m2 during radiation therapy
Radiation: radiation · Drug: weekly cisplatin
cisplatin 75mg/m2 three cycles, every 3 weeks
Radiation: radiation · Drug: tri-weekly cisplatin
radiation with cisplatin 40mg/m2, 6 cycles, every week
weekly cisplatin 40mg/m2, 6 cycles
Also known as: Cisplatin
cisplatin 75mg/m2, 3cycles, every 3 weeks
Also known as: Cisplatin
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Korea Cancer Center Hospital