Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 598
- 试验地点
- 3
- 主要终点
- disease free survival
研究概览
简要总结
The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.
详细描述
The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.
Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.
The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix
- •FIGO clinical stage IB2-IIB with pelvic lymph node metastasis or FIGO clinical stage III-IVA with or without pelvic lymph node metastasis
- •ECOG performance score 0-1
- •The bone marrow, hepatic and renal function was normal at registration
- •The patients signed informed consent
排除标准
- •clear cell and small cell neuroendocrine, sarcoma
- •FIGO stage IVB
- •Prior invasive malignancy
- •Prior systemic chemotherapy
- •Prior radiotherapy to the pelvis or abdomen
- •Severe, active co-morbidity
- •Women who are pregnant
- •immunocompromised status
研究组 & 干预措施
experimental
concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.
During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.
After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;
The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
docetaxel 75mg/m2, d43,d64.
干预措施: concurrent chemotherapy with cisplatin (Drug)
experimental
concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.
During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.
After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;
The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
docetaxel 75mg/m2, d43,d64.
干预措施: concurrent chemotherapy with docetaxel (Drug)
experimental
concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.
During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.
After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;
The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
docetaxel 75mg/m2, d43,d64.
干预措施: pelvic radiotherapy (Radiation)
experimental
concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.
During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.
After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;
The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
docetaxel 75mg/m2, d43,d64.
干预措施: brachytherapy (Radiation)
experimental
concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.
During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.
After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;
The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
docetaxel 75mg/m2, d43,d64.
干预措施: adjuvant chemotherapy with cisplatin and docetaxel (Drug)
control
standard chemoradiotherapy with weekly cisplatin.
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.
Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
干预措施: concurrent chemotherapy with cisplatin (Drug)
control
standard chemoradiotherapy with weekly cisplatin.
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.
Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
干预措施: pelvic radiotherapy (Radiation)
control
standard chemoradiotherapy with weekly cisplatin.
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.
Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
干预措施: brachytherapy (Radiation)
结局指标
主要结局
disease free survival
时间窗: 3 year
次要结局
- overall survival(3 year)
研究者
Mei Shi
chair of department
Air Force Military Medical University, China