Phase III Randomized Study of Concurrent Paclitaxel/Cisplatin Chemotherapy and Radiotherapy With or Without Consolidation Chemotherapy in High-Risk Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage
cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy
plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph
node metastasis, the involvement of vaginal resection margin, and the parametrial invasion,
have been identified to compromise the patient prognosis.
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment
for patients with cervical cancer. However, many patients with pathological risk factors
treated with concurrent radiotherapy plus single agent cisplatin still suffered from the
local or distant relapse. How to improve the treatment outcome of these patients is a very
important issue and requires further clinical investigation.
Paclitaxel has been demonstrated to be a good radiosensitizer. In addition,
paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior
progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is
not yet known whether chemotherapy and radiation therapy are more effective when given with
consolidation chemotherapy in treating cervical cancer.
Therefore, the investigators are going to perform the efficacy and safety study of
postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with
consolidation chemotherapy in high-risk patients with early-stage cervical cancer following
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
China: Food and Drug Administration