The Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer But Without the Criteria for Adjuvant Radiotherapy According to NCCN Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Progress Free Survival (PFS)
研究概览
简要总结
This study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Patients will be randomly divided into two groups in a 1:1 ratio. The experimental group received 4 courses of paclitaxel and cisplatin (once every 3 weeks) for adjuvant chemotherapy within 4 weeks after surgery, while the control group don't not receive any adjuvant therapy but only received regular follow-up. The disease status of all patients will be evaluated within 4 weeks after the end of all treatment and every 12 weeks thereafter, including gynecological examination, laboratory indicators, imaging evaluation, and the prognosis of the two groups will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The age of patients is 18-70 years old.
- •Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).
- •Clinical stage is IB1-IB2 according to FIGO 2018 stage.
- •The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.
- •The degree of tumor differentiation is poorly differentiated.
- •Do not meet the Sedlis criteria or the four-factor model, but meet one of the following factors: ① LVSI (+); ② tumor diameter > 2cm; ③ Depth of cervical stromal invasion > superficial 1/3; (4) adenocarcinoma.
排除标准
- •Postoperative pathological stage ≥IIA (according to the 2018 FIGO staging system).
- •Patients with the following high risk factors: ① lymph node metastasis; ② parametrial involvement; ③ positive surgical margin; ④ vaginal involvement.
- •Patients received neoadjuvant chemotherapy.
- •There was evidence of distant metastasis on preoperative imaging examination.
- •Patients received postoperative radiotherapy.
- •History of abdominal or pelvic radiotherapy.
- •Patients with other malignant tumors.
- •Patients with missing or partially missing clinical, surgical, and pathological data were lost to follow-up.
结局指标
主要结局
Progress Free Survival (PFS)
时间窗: 5 years
The time between surgery and clinical recurrence.
次要结局
- Overall Survival (OS)(5 years)