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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.
详细描述
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 radical hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type)
- •One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement)
- •Eastern Cooperative Oncology Group 0-2
- •Expected life span over 6 months.
- •No distant metastasis
- •Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
- •Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- •Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
- •Written informed consent
排除标准
- •Previous history of chemotherapy or radiation
- •Hypersensitive reaction to platinum/paclitaxel agent
- •History of other cancer
- •Concurrent systemic illness not appropriate for chemotherapy
- •Active infection requiring antibiotics
- •Pregnancy
- •Metastasis to paraaortic lymph node
研究组 & 干预措施
Arm 1
Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: paclitaxel (Drug)
Arm 1
Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
Arm 1
Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: radiotherapy (Radiation)
Arm 2
Patients receive chemoradiotherapy as in arm 1.
干预措施: paclitaxel (Drug)
Arm 2
Patients receive chemoradiotherapy as in arm 1.
干预措施: cisplatin (Drug)
Arm 2
Patients receive chemoradiotherapy as in arm 1.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
disease-free survival
时间窗: 3 years
次要结局
- overall survival(5 years)
研究者
xie congying
Director
Wenzhou Medical University