Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Disease free survival in PHENIX-II
研究概览
简要总结
The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.
详细描述
This study comprises two parts: PHENIX-I: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with negative sentinel lymph node; PHENIX-II: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with positive sentinel lymph node. Patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical cancer are eligible for our study. The tumor diameter should be less than 3cm. Sentinel lymph node biopsy will be performed at the beginning of operations. After pathological examination of frozen section, patients will be assigned to PHENIX-I or PHENIX-II study according to their status of sentinel nodes. In both parts of this trail, patients have equal chance to be randomly assigned to experimental arms (radical hysterectomy only) and reference arms (radical hysterectomy and pelvic lymphadenectomy).Adjuvant treatments will be planned according to postoperative pathological factors. The primary objective is disease-free survival at 3 years for PHENIX-I and 2 years for PHENIX-II. The secondary end points are overall survival, long-term outcome of sentinel lymph node biopsy 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 squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
- •Original clinical stage must be FIGO (2018) stage IA1 (lymphovascular space involvement), IA2, IB1, IB2 and IIA1
- •No suspected node should be found on imaging examination (RESIST 1.1)
- •Age between 18-65
- •Patients must give signed informed consent
- •P.S status: 0-1
- •Estimated survival time > 3 months
- •Tumor diameter ≤ 3 cm
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
- •The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection
- •History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease
- •Gestation or perinatal period
- •Intention to fertility preservation.
结局指标
主要结局
Disease free survival in PHENIX-II
时间窗: 2 years
Disease free survival in PHENIX-I
时间窗: 3 years
次要结局
- Patients' quality of life(5 years)
- Overall survival(5 years)
- Surgical morbidity(3 years)
- Rate of retroperitoneal node recurrence(3 years)
- Anatomic distribution of SLNs(3 years)
- Performance of SLN detection(3 years)
- Diagnostic accuracy of frozen section examination(3 years)
研究者
Jihong Liu
Prof.
Sun Yat-sen University