Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients
Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
研究概览
详细说明
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.
Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Zhejiang
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Wenzhou、Zhejiang、中国、325000
- 招聘中
- The First Affiliated Hospital of Wenzhou Medical College
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接触：
- congying xie, MD
- 电话号码：+86-577-88069316
- 邮箱：wzxiecongying@163.com
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首席研究员：
- congying xie, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type)
- Negative lymph node
- At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Arm 2
Patients receive radiotherapy alone as in arm 1.
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实验性的：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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无病生存
大体时间：3年
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3年
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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总生存期
大体时间：5年
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5年
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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将不良事件作为安全性和耐受性衡量标准的参与者人数
大体时间：1年
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由 NCI Common Terminology Criteria v3.0 评估
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1年
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合作者和调查者
赞助
调查人员
- 研究主任：Congying Xie, MD、the 1st Affiliated Hospital of Wenzhou Medical College
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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