Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective pathologic response
研究概览
简要总结
This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results.
The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH.
The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- •FIGO stage IB2 to IIB
- •Type II or III radical hysterectomy or trachelectomy
- •Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1
- •Aged 18 years to 45 years
- •Well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy
- •Signed an approved informed consents
排除标准
- •Not satisfying any of the inclusion criteria
研究组 & 干预措施
Group A
Patients in group A don't receive neoadjuvant chemotherapy
干预措施: First imaging evaluation (Diagnostic Test)
Group A
Patients in group A don't receive neoadjuvant chemotherapy
干预措施: Radiochemotherapy (Radiation)
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
干预措施: Two cycles of neoadjuvant chemotherapy (Drug)
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
干预措施: First imaging evaluation (Diagnostic Test)
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
干预措施: Second imaging evaluation (Diagnostic Test)
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
干预措施: The third cycles of neoadjuvant chemotherapy (Drug)
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
干预措施: RH (Procedure)
Group B
Patients in group B receive neoadjuvant chemotherapy and achieve imaging response
干预措施: Pathologic evaluation (Diagnostic Test)
Group C
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
干预措施: Two cycles of neoadjuvant chemotherapy (Drug)
Group C
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
干预措施: First imaging evaluation (Diagnostic Test)
Group C
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
干预措施: Second imaging evaluation (Diagnostic Test)
Group C
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy
干预措施: Radiochemotherapy (Radiation)
Group D
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
干预措施: Two cycles of neoadjuvant chemotherapy (Drug)
Group D
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
干预措施: First imaging evaluation (Diagnostic Test)
Group D
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
干预措施: Second imaging evaluation (Diagnostic Test)
Group D
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
干预措施: RH (Procedure)
Group D
Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy
干预措施: Pathologic evaluation (Diagnostic Test)
结局指标
主要结局
Objective pathologic response
时间窗: 3 years
Objective pathologic response for patients with radical hysterectomy
Objective imaging response
时间窗: 3 years
Objective imaging response for patients with neoadjuvant chemotherapy
次要结局
- Disease-free survival(3 years)
- Overall survival(3 years)
- Severe adverse events(1 year)
研究者
Lei Li
Professor
Peking Union Medical College Hospital