A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 743
- 试验地点
- 195
- 主要终点
- Overall Survival (Percentage of Participants Alive)
研究概览
简要总结
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.
PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection.
Secondary
- Compare local-regional control of disease and disease-free rates in patients treated with these regimens.
- Compare the acute and late toxicity of these regimens in these patients.
- Compare quality of life, perception of side effects, and performance status of patients treated with these regimens.
- Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard fractionation RT + cisplatin
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
干预措施: cisplatin (Drug)
Standard fractionation RT + cisplatin
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
干预措施: Standard fractionation RT (Radiation)
Standard fractionation RT + cisplatin
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
干预措施: Conventional surgery for select patients (Procedure)
Accelerated fractionation RT + cisplatin
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
干预措施: cisplatin (Drug)
Accelerated fractionation RT + cisplatin
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
干预措施: Accelerated fractionation radiation therapy (Radiation)
Accelerated fractionation RT + cisplatin
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
干预措施: Conventional surgery for select patients (Procedure)
结局指标
主要结局
Overall Survival (Percentage of Participants Alive)
时间窗: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
次要结局
- Local-regional Failure (Percentage of Participants With Local-regional Failure)(From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
- Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure](From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
- Disease-free Survival (Percentage of Participants Alive Without Disease)(From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
- Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression](From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
- Percentage of Participants With Toxicity Grade 3 or Higher(From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.)
- Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year(Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.)
- PSS-HN Public Eating Score - AUC at One Year(Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.)
- PSS-HN Understandability of Speech Score - AUC at One Year(Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.)
- Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year(Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.)
- Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes(From randomization to date of death or last follow-up)
- Correlation of COX-2 With Outcomes(From randomization to date of death or last follow-up)