Cervical Cancer Clinical Trial
Official title:
A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy
The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel/carboplatin is effective and safe in the treatment of high risk cervical cancer patients.
Stage Ib to IIa cervical cancer can be treated effectively with either radioterapy or
radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk
factors have been identified to compromise the treatment outcome. They include lymph node
metastasis, the involvement of vaginal resection margin, and the parametrial invasion. In
these patients, postoperative RT is commonly recommended and has been demonstrated to
improve the local control, but not survival rate. Recently, It is reported that the additon
of concurrent chemotherapy to postoperative RT reduced pelvic failures and enhanced
progression free survival. In addition, paclitaxel/platinum combination chemotherapy was
demonstrated to have superior progression-free survical over single agent platinum in a
primary treatment of stage IV or recurrent cervical cancer.
Based on this obseration, we evaluated the efficacy and safety of CCRT with
paclitaxel/carboplatin in patients with postoperative high risk factors.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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