A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel/Carboplatin Chemotherapy in High-risk Cervical Cancer Patients After Radical Hysterectomy
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Two year disease free survival
Soon Beom Kang, Professor
Study Chair
Korean Gynecologic Oncology Group
Korea: Food and Drug Administration
KGOG1001
NCT00340184
August 2004
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