Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.
详细描述
- Objective:
To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT. 2. Patients:
- Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B 点 50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）
- MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
- Methods:
The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- •Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B 点 50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
- •MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
- •Expected survival is longer than six months
- •Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
- •ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
- •The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
排除标准
- •Activity or uncontrol severe infection
- •Liver cirrhosis, Decompensated liver disease
- •History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
- •Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
- •Have suffered or combined with other malignant tumor
- •Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- •A history targeted therapy or pelvic artery embolization
- •Artery-enous thrombosis within 6 months
- •Patients with autoimmune diseases
- •Complications, need to be treatment with drugs which may lead to liver or kidney injury
- •Patients with disease progression after chemoradiation
研究组 & 干预措施
control group
In this group, observation is given after CCRT.
干预措施: CCRT (Radiation)
trial group
In this group, adjuvant chemotherapy is given after CCRT.
干预措施: CCRT (Radiation)
trial group
In this group, adjuvant chemotherapy is given after CCRT.
干预措施: Paclitaxel, Cisplatin (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
Progression-free survival
次要结局
- ORR(3 months)
- OS(5 years)
研究者
Dongling Zou
Associated Director
Chongqing University Cancer Hospital