A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 3
- 主要终点
- disease-free survival (DFS)
研究概览
简要总结
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage: ⅠB～ⅡA, cervical cancer;
- •Age≤60 years; female, Chinese women;
- •Initial treatment is radical hysterectomy + pelvic lymph node dissection;
- •Pathological diagnosis: cervical squamous cell invasive carcinoma;
- •Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter> 4cm;
- •Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
- •Performance status: Karnofsky score≥60;
- •No prior treatment;
- •Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma;
- •Provide written informed consent.
排除标准
- •With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
- •History of organ transplantation, immune diseases;
- •History of serious mental illness, a history of brain dysfunction;
- •Drug abuse or a history of drug abuse;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
研究组 & 干预措施
Adjuvant Chemotherapy (Arm A)
Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary.
干预措施: radical hysterectomy + pelvic lymph node dissection (Procedure)
Adjuvant Chemotherapy (Arm A)
Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary.
干预措施: Paclitaxel (Drug)
Adjuvant Chemotherapy (Arm A)
Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary.
干预措施: Cisplatin (Drug)
Concurrent radiochemotherapy, CCRT (Arm B)
Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks.
干预措施: radical hysterectomy + pelvic lymph node dissection (Procedure)
Concurrent radiochemotherapy, CCRT (Arm B)
Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks.
干预措施: Cisplatin (Drug)
Concurrent radiochemotherapy, CCRT (Arm B)
Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks.
干预措施: Pelvic RT (Radiation)
结局指标
主要结局
disease-free survival (DFS)
时间窗: up to 3-year
DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
次要结局
- Quality of Life in two arms(3 years)
- 3-year overall survivals (OS)(3-year)
- chemotherapy- and radiotherapy- related adverse effects respectively in two arms(3 years)
研究者
Ding Ma
Director of Department of Gynecology and Obstetrics
Huazhong University of Science and Technology