Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 2
- 主要终点
- Chemotherapy completion rate
研究概览
简要总结
Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.
详细描述
This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity
- •Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU
- •Age ≤ 70 years
- •No previous treatment for head and neck cancer
- •No distant metastases
排除标准
- •Previous treatment for head and neck cancer
- •Distant metastases
研究组 & 干预措施
Carboplatin plus 5-FU
Patients treated with carboplatin plus 5-FU
干预措施: carboplatin (Drug)
Concomitant cisplatin
Patients treated with concomitant cisplatin
干预措施: cisplatin (Drug)
Carboplatin plus 5-FU
Patients treated with carboplatin plus 5-FU
干预措施: 5-FU (Drug)
结局指标
主要结局
Chemotherapy completion rate
时间窗: 1 year
The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.
次要结局
- Distant metastases(1 year)
- Progression free survival(1 year)
- Overall survival(1 year)
- Late toxicity(1 year)
- Grade 3-4 acute toxicity(1 year)
- Quality of life(1 year)