Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: 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
- 540
- 试验地点
- 8
- 主要终点
- 5-year local-recurrence-free survival (5y-LRFS)
研究概览
简要总结
Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, 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. The early stage diseases (Stage Ia, Ib and IIa1) is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events (incidence 18-35%) of radical resection. When adjuvant radiotherapy (ART) is performed, lymphocyst is included in the clinical target volume (CTV) with a dose of 45-50Gy, in most hospitals of China. However, there is no pathologic and clinical evidence that lymphocyst is associated with local recurrence. However, inclusion of lymphocyst might enlarge CTV and increase irradiation dose of organs at risk (OARs) such as small intestine and kidneys. 2. Objective
The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate. 3. Patients and methods
A patient will be enrolled when patient have:
- pathologically diagnosed cervical cancer;
- Stage I-II diseases (FIGO system ver. 2014);
- treated with radical resection;
- need of ART according to NCCN guidelines ver. 2016v2.
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
- •Patients with pathological diagnosed cervical cancer and treated with radical resection
- •Stage I-II diseases (FIGO system ver. 2014)
- •Karnofsky Performance Scores ≥ 80 and expected survival ≥ 3 months
- •Pelvic MRI or CT indicate existence of lymphocyst
- •Need of adjuvant radiotherapy according to NCCN guidelines ver. 2016v2 (SEDLIS criteria)
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
- •Prior chemotherapy, radiotherapy or application of monoclonal antibodies
- •Patients participated in clinical trials of other drugs within last 3 months
- •Pregnant or lactating women
- •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, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
干预措施: Cisplatin (Drug)
The control group (Group A)
In Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
干预措施: Radiation Method A (Radiation)
The experiment group (Group B)
In Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
干预措施: Radiation Method B (Radiation)
The experiment group (Group B)
In Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
干预措施: Cisplatin (Drug)
结局指标
主要结局
5-year local-recurrence-free survival (5y-LRFS)
时间窗: 5 years after the date of radiotherapy completion
Percentage of patients in a treatment group who are alive without local recurrence for a 5-year period of follow-up after the date of radiotherapy completion
次要结局
- 5-year overall survival (5y-OS)(5 years after the date of radiotherapy completion)
- Incidence of grade 3/4 adverse event(Once a week during therapy, up to 5 years after the date of radiotherapy completion)
研究者
Wei-jun Ye
Professor
Sun Yat-sen University