Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.
In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.
详细描述
After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.
We have recruited 800 patients till November 2014.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed cervical carcinoma
- •Original clinical stage must be Ib~IIa （FIGO）
- •Age between 18-65
- •With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
- •More than 3 months survival is to expect
- •Patients must give signed informed consent
排除标准
- •The presence of uncontrolled life-threatening illness
- •Receiving other ways of anti-cancer therapy
- •Residual tumor which can not be removed in the surgery
- •Investigator consider the patients can't finish the whole study
- •With normal liver function test (ALT、AST>2.5×ULN)
- •With normal renal function test (Creatinine>1.5×ULN)
- •WBC<4,000/mm3 or PLT<100,000/mm3
- •Receive the external pelvic irradiation before the surgery
研究组 & 干预措施
Radiotherapy (RT)
Radiotherapy
干预措施: Radiotherapy (RT) (Radiation)
Concurrent chemoirradiation (CCRT)
Concurrent chemoirradiation:
External beam radiation with concurrent weekly platinum chemotherapy
干预措施: Concurrent chemoirradiation (CCRT) (Other)
Sequence chemo and radiation (SCRT)
Sequence chemotherapy and radiotherapy:
2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation
干预措施: Sequence chemotherapy and radiotherapy (SCRT) (Other)
结局指标
主要结局
Disease Free Survival
时间窗: 3-Yr
DFS survival analysis
次要结局
- Overall Survival(5-Yr)
研究者
Jihong Liu
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Sun Yat-sen University