Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.
详细描述
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with newly histologically confirmed cervical carcinoma
- •Original clinical stage must be IIB （FIGO 2009）
- •Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
- •Age between 18-65
- •Patients must give signed informed consent
排除标准
- •The presence of uncontrolled life-threatening illness
- •Receiving other ways of anti-cancer therapy
- •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
研究组 & 干预措施
Concurrent chemoirradiation (CCRT)
Concurrent chemoirradiation
干预措施: Concurrent chemoirradiation (Radiation)
NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
干预措施: Paclitaxel (Drug)
NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
干预措施: Radical Surgery (Procedure)
NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
干预措施: Cisplatin (Drug)
结局指标
主要结局
Disease free survival
时间窗: 5 years
次要结局
- Overall survival(5 years)
研究者
Jihong Liu
Sun Yat-sen University Cancer Center
Sun Yat-sen University