Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.
- •Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
- •Age：18-70 years old.
- •ECOG status score ≤1;
- •WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
- •Well-compliance and willing to keep in touch.
- •Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.
排除标准
- •After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
- •Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
- •Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
- •Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
- •Participate in other clinical trials.
- •Severe diseases of other important systems and organs.
- •Persons without disposing capacity.
- •Drug and/or alcohol abuse.
- •Unable or unwilling to sign informed consents.
- •Not eligible for the study judged by researchers.
研究组 & 干预措施
Adjuvant chemotherapy group
Participant will receive at least 2 cycles of adjuvant chemotherapy. If having any of the following factors, participant will receive additional 2 cycles of adjuvant chemotherapy per risk factor. All patients received maximum 6 cycles of postoperative chemotherapy.
Risk factors: (1) Deep cervical invasion（≥ 2/3）；（2）Differentiation grade 2-3；（3）Lymphatic vascular space infiltration；（4）Adenocarcinoma or adenosquamous carcinoma；（5）Tumor size ≥ 4cm before surgery.
干预措施: Adjuvant chemotherapy (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 5 year
DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.
次要结局
- Quality of Life Outcomes of cervical cancer(5 years)
- Quality of Life Outcomes(5 years)
- Incidence of Toxicity(5 years)
- Overall survival （OS）(5 year)
研究者
Ding Ma
Tongji Hospital, Tongji Medical College
Huazhong University of Science and Technology