A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.
详细描述
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB2 and IIA2 cervical cancer are eligible for our study. They will receive paclitaxel + cisplatin(TP)/carboplatin(TC) regimen neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or directly radical surgery (arm B). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival, The secondary end points is overall survival , rate of response to TP or TC regimen chemotherapy and the quality of life.
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 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;
- •Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma;
- •Original clinical stage must be IB2 or IIA2 （FIGO);
- •Age between 18-65;
- •Patients must give signed informed consent;
- •P.S status: 0-1;
- •Estimated survival time > 3 months;
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/mm;
- •Accompany with other malignancy.
研究组 & 干预措施
A(NACT)
Neoadjuvant Chemotherapy followed by Radical Surgery
干预措施: NACT (Paclitaxel + Cisplatin or carboplatin) (Drug)
A(NACT)
Neoadjuvant Chemotherapy followed by Radical Surgery
干预措施: radical surgery (Procedure)
B(RS)
Radical Surgery alone
干预措施: radical surgery (Procedure)
结局指标
主要结局
Disease free survival
时间窗: 2 years
次要结局
- quality of life(3 years)
- overall survival(5 years)
研究者
Jihong Liu
Prof.
Sun Yat-sen University