Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 432
- 试验地点
- 8
- 主要终点
- 3-year progression-free survival (3y-PFS)
研究概览
简要总结
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.
详细描述
- Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.
- Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .
- Patients
A patient will be enrolled when patient have:
- Pathologically diagnosed cervical cancer;
- pelvic or para-aortic lymph metastases, at least match one of following
- CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
- pelvic or para-aortic lymph node shows necrosis or extra capsular spread
- PET/CT scan finds positive pelvic or para-aortic node lymph node
- biopsy confirms lymph metastase
- Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- Karnofsky Performance Scores ≥ 70;
4.Method
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed cervical cancer;
- •pelvic or para-aortic lymph metastases, at least match one of following
- •CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
- •pelvic or para-aortic lymph node shows necrosis or extra capsular spread
- •PET/CT scan finds positive pelvic or para-aortic node lymph node
- •biopsy confirms lymph metastase
- •Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- •Karnofsky Performance Scores ≥ 70;
排除标准
- •Patients with distant metastasis before or during radiotherapy
- •Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
- •Severe neurological, mental or endocrine diseases
- •History of other malignancies
- •Those who are considered by the researchers unsuitable to participate -
研究组 & 干预措施
The control group (Group A)
In Group A, observation is given after chemoradiation
干预措施: chemoradiation (Radiation)
The experiment group (Group B)
in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.
干预措施: chemoradiation (Radiation)
The experiment group (Group B)
in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.
干预措施: Paclitaxel, Cisplatin (Drug)
结局指标
主要结局
3-year progression-free survival (3y-PFS)
时间窗: 3 years after the date of adjuvant chemotherapy completion
Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion
次要结局
- Incidence of grade 3/4 adverse event(Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion)
研究者
Wei-jun Ye
Professor
Sun Yat-sen University