Phase III Study Comparing Neoadjuvant Chemotherapy With Carboplatin and Paclitaxel Followed by Standard Therapy, With Standard Therapy Alone in Women With Cervical Cancer and Para Aortic Positive Lymph Node.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 11
- 主要终点
- Overall survival
研究概览
简要总结
The main objective of this study is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement.
Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy. Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy.
310 patients will be recruited during 4.5 years, with 3 years of follow up period.
详细描述
The survival outcome of patients with carcinoma of the cervix and positive paraaortic lymph node is poor and the potential benefit of neoadjuvant chemotherapy before extended field chemoradiotherapy has never been assessed.
Paraaortic nodal spread in cervical cancer is a blind spot in the management of cervical cancer. It is necessary to evaluate additional treatment.
While the presence of paraaortic nodal metastases often indicates occult systemic disease, the investigators continue to treat them as a loco-regional disease.
Using neoadjuvant chemotherapy, improvement of overall survival rates is expected in women with cervical cancer and para-aortic positive lymphadenopathy without increasing the incidence of further toxicity.
The propose is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically proven invasive carcinoma of the uterine cervix and para aortic lymphadenopathy determined by either a positive positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography or if negative positron emission tomography computed tomography based on histological examination of paraaortic lymph node dissection.
- •Performance status Eastern Cooperative Oncology Group 0-2
- •Stage International Federation of Gynecology and Obstetrics IB1 to IVA at diagnosis with para-aortic lymph node involvement
- •Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma
- •Adequate renal function (creatinine clearance ≥60 mL/min)
- •Adequate hepatic function (bilirubin <1.5 times normal and Serum Glutamooxaloacetate Transferase < 3 times normal)
- •Adequate hematopoietic function Platelet count > 100x10 9/l and Absolute neutrophil count > 1.5X10 9/l)
- •Written Informed consent for participation
排除标准
- •Stage Federation of Gynecology and Obstetrics IVB at diagnosis
- •Others histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma.
- •Women who receive any prior chemotherapy for her cervical cancer
- •Pregnant or lactating women
- •Prior ( within the last 5 years) malignancies other than non-melanoma skin cancer
- •Inadequate renal, hepatic or hematopoietic function (Cf previously)
- •Cardiovascular pathology New York Heart Association II or more
- •Pre-existing Peripheral neuropathy Common toxicity Criteria grade ≥ 2
研究组 & 干预措施
Neoadjuvant chemotherapy+standard therapy
neoadjuvant chemotherapy with carboplatin aera Under curve 5 and paclitaxel 175 mg/m² every 21 days during 3 cycles followed by standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
干预措施: Carboplatin (Drug)
Neoadjuvant chemotherapy+standard therapy
neoadjuvant chemotherapy with carboplatin aera Under curve 5 and paclitaxel 175 mg/m² every 21 days during 3 cycles followed by standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
干预措施: Paclitaxel (Drug)
Neoadjuvant chemotherapy+standard therapy
neoadjuvant chemotherapy with carboplatin aera Under curve 5 and paclitaxel 175 mg/m² every 21 days during 3 cycles followed by standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
干预措施: Cisplatin (Drug)
Neoadjuvant chemotherapy+standard therapy
neoadjuvant chemotherapy with carboplatin aera Under curve 5 and paclitaxel 175 mg/m² every 21 days during 3 cycles followed by standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
干预措施: Radiotherapy (Radiation)
standard therapy alone
standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
干预措施: Cisplatin (Drug)
standard therapy alone
standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: 3 years
time between random assignment and death resulting from any cause
次要结局
- quality of life questionnaire C30 and CX24(3 years)
- progression free survival(fron date of randomization until the date of first documented progression or date of death from any cause, assessed up to 3 years)
- patterns of first relapse(3 years)
- adverse events(3 years)