NCT00122460已完成3 期
Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Overall Survival Time (OS)
研究概览
简要总结
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
- •Recurrent and/or metastatic SCCHN, not suitable for local therapy
排除标准
- •Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
- •Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
- •Nasopharyngeal carcinoma
研究组 & 干预措施
Cetuximab Plus Chemotherapy
Experimental
干预措施: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) (Drug)
Chemotherapy alone
Active Comparator
干预措施: Platinum (Cisplatin or Carboplatin) + 5-FU (Drug)
结局指标
主要结局
Overall Survival Time (OS)
时间窗: time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
次要结局
- Progression-free Survival Time (PFS)(time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
- Best Overall Response(evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
- Disease Control(evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
- Time to Treatment Failure(Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
- Duration of Response(time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007)
- Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status(at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007)
- Quality of Life Assessment (EORTC QLQ-C30) Social Functioning(at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007)
- Safety - Number of Patients Experiencing Any Adverse Event(time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal CancerNeoplasm MetastasisLiver NeoplasmsColorectal NeoplasmsNCT01564810Xu jianmin150
已完成
3 期
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)Non Small Cell Lung Cancer (NSCLC)NCT00148798Merck KGaA, Darmstadt, Germany1,861
进行中（未招募）
2 期
Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic CarcinomaThymic CarcinomaClinical Masaoka Stage II to IVAThymomaNCT01025089Memorial Sloan Kettering Cancer Center18
招募中
2 期
Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal CancerLocally Advanced Colorectal CarcinomaNCT06154538Cancer Institute and Hospital, Chinese Academy of Medical Sciences170
已完成
2 期
A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric CancerGastric CancerNCT00477711Peking University41