Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 234
- 主要终点
- Patient tolerance of the treatment regimen
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine the patterns of failure in patients treated with this regimen.
OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.
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
- 21 Years 至 —（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
Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
干预措施: cisplatin (Drug)
Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
干预措施: paclitaxel (Drug)
Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
干预措施: conventional surgery (Procedure)
Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Patient tolerance of the treatment regimen
时间窗: From registration to end of treatment
次要结局
- Frequency of grade 5 and acute non-hematologic grade 4 toxicity(From start of induction chemotherapy to 90 days after start of radiation therapy)
- Frequency of other acute and late toxicity(From start of induction chemotherapy to last follow-up)
- Local-regional control(From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.)
- Disease-free survival(From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years.)
- Overall survival(From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.)