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临床试验/NCT01999933
NCT01999933Unknown2 期

Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer

Mei Shi1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
600
试验地点
1
主要终点
overall survival

研究概览

简要总结

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

详细描述

To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

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

入选标准

  • 18 Years to 70 Years
  • Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
  • Accepted radical hysterectomy 3-4 weeks before
  • Karnofsky score >70
  • Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.
  • Examination results showed no radiation or chemotherapy contraindication
  • Willing to accept treatment
  • Ability to comply with trial requirements

排除标准

  • Postoperative residual
  • Postoperative recurrence or metastasis
  • Without lymph node dissection
  • Postoperative pathology showed aortic lymph node metastasis
  • Examination results showed radiotherapy contraindications
  • No indications for radiotherapy

研究组 & 干预措施

CCRT with cisplatin(DDP) weekly

Active Comparator

concurrent chemotherapy: cisplatin(DDP) weekly, 40mg/m2, begin with radiation

干预措施: Radiation (Radiation)

CCRT with cisplatin(DDP) weekly

Active Comparator

concurrent chemotherapy: cisplatin(DDP) weekly, 40mg/m2, begin with radiation

干预措施: cisplatin(DDP) weekly (Drug)

CCRT with TP

Experimental

concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation

干预措施: Radiation (Radiation)

CCRT with TP

Experimental

concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation

干预措施: docetaxel plus cisplatin (Drug)

concurrent and adjuvant TP

Experimental

2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation

干预措施: Radiation (Radiation)

concurrent and adjuvant TP

Experimental

2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation

干预措施: docetaxel plus cisplatin (Drug)

结局指标

主要结局

overall survival

时间窗: 5-years

次要结局

  • disease-free survival(5 years)
  • acute adverse events(3 months)
  • chronic adverse events(3 years)

研究者

发起方
Mei Shi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mei Shi

Director and Professor of Department of Radiation Oncology, Xijing Hospital

Air Force Military Medical University, China

研究点 (1)

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