At a glance
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Safety and Efficacy of Gemcitabine Based Neoadjuvant Chemotherapy Followed by Chemoradiation in Locally Advanced Cervical Cancer Patients and Association With Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
In Brief
A Phase 2 clinical trial evaluating gemcitabine, cisplatin, and 1 other intervention for Cancer of Cervix. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The propose of this study is to determine if neoadjuvant chemotherapy followed by chemoradiation is safe and effective in locally advanced cervical cancer patients. Moreover, the study would determine if there is any association between hENT1 expression and response rate to gemcitabine.
Study Details
Timeline
Interventions
Patients received intravenous 500-1000 ml normal saline and antiemetic medication before chemotherapy. Treatment consisted of intravenous gemcitabine at a dose of 1000 mg/m2 diluted in 500 ml of normal saline administered over 30 minutes mg/m2 diluted in 500 ml of normal saline administered over 30 minutes on days 1 and 8, followed by cisplatin 35 mg/m2 administered over 2 hours on day 1 and 8.
35 mg/m2 administered over 2 hours on day 1 and 8.
external beam radiotherapy concomitant with weekly cisplatin 40mg/m2