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Clinical trial

Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer

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Last updated:18th Sep 2009
This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both PAN + pelvis arm and pelvis only arm. This study includes a translational research component in that all the primary tumors are stained with CA9, a hypoxia marker, before randomization. According to our study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). Primary cervical cancer tissues are examined for expression of CA9 just after registration, and before the patients are randomized to each arm (pelvis only vs. EFI). We expect a higher benefit of EFI in patients with CA9-positive tumors.
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Study start date 2009-09-18

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