Phase II Randomized Assessing Pelvic Irradiation Combined With Cisplatin Alone or Cisplatin Plus Cetuximab in Patients With Carcinoma of the Cervix Stage IB2, II and III
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Recurrence-free survival at 2 years
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy given together with cisplatin is more effective with or without cetuximab in treating patients with cervical cancer.
PURPOSE: This randomized phase II trial is studying giving radiation therapy together with cisplatin to see how well it works compared with radiation therapy and cisplatin given together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of treatment with cetuximab and a standard radiochemotherapy regimen (pelvic radiotherapy and cisplatin) in patients with stage IB2, II, and IIIB cervical cancer by evaluating the number of patients without recurrence at 2 years.
Secondary
- Analyze the tumor response by MRI after external radiotherapy.
- Assess the tolerance of cetuximab and standard radiochemotherapy in patients not previously treated and in generally good condition.
- Study the correlation between treatment response and analysis of EGFR mutations (exons 18-21 of the tyrosine kinase domain including the two hot spots L858R and E746-A750).
- Study the correlation between treatment response and evaluation of number of copies of the EGFR gene.
- Study the correlation between treatment response and analysis of mutations of codons 12 and 13 of KRAS2 by direct sequencing.
- Study the correlation between treatment response and research of DNA sequences of human papillomavirus.
- Study the correlation between treatment response and overexpression of EGFR and COX2 (centralized) by IHC.
- Study the correlation between treatment response and characterization of a genomic signature (genome, transcriptome, and Affymetrix chips from samples frozen in liquid nitrogen).
- Collect tumor samples for molecular analysis.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive cisplatin IV over 1 hour once weekly during weeks 1-6. Patients also undergo pelvic radiotherapy 5 days a week during weeks 2-5 or 2-6.
干预措施: cisplatin (Drug)
Arm II
Patients receive cisplatin and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1 hour once weekly during weeks 1-6.
干预措施: cetuximab (Biological)
Arm II
Patients receive cisplatin and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1 hour once weekly during weeks 1-6.
干预措施: cisplatin (Drug)
结局指标
主要结局
Recurrence-free survival at 2 years
次要结局
- Response as assessed by MRI after radiochemotherapy and before surgery according to RECIST criteria
- Toxicity according to NCI CTCAE v3.0