Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with cetuximab and radiation therapy works in treating patients with locally advanced head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the progression-free survival of patients with locally advanced squamous cell carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by concurrent cetuximab and radiotherapy.
Secondary
- Assess the objective response rate in patients treated with this regimen.
- Assess the best overall response rate, overall survival, local-regional control, and distant failure in patients treated with this regimen.
- Assess the acute and long-term toxicity associated with this regimen in these patients.
- Assess quality of life and swallowing in patients treated with this regimen.
- Determine the accuracy of PET/CT scan in evaluating objective response; in detecting residual disease at primary sites and nodes; in guiding the recommendation for salvage surgery or for neck dissection; and in early detection of recurrent or metastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 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
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: computed tomography (Procedure)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: cetuximab (Biological)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: cisplatin (Drug)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: docetaxel (Drug)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: fluorouracil (Drug)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: positron emission tomography (Procedure)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: quality-of-life assessment (Procedure)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: 3-dimensional conformal radiation therapy (Radiation)
TPFChemotherapy + Concomitant Cetuximab & RT
Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab & Radiation Therapy
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Progression-free Survival
时间窗: up to 2 years
次要结局
- Number of Participants With Distant Metastasis(up to 2 years)
- Objective Response Rate(up to 2 years)
- Best Overall Response Rate(up to 2 years)
- MD Anderson Dysphagia Inventory(Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years)
- Overall Survival(up to 2 years)
- Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years)
- Number of Participants With Local-Regional Control(up to 2 years)
- Performance Status Scale for Head and Neck Cancer(Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years)