Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 9
- 主要终点
- Rate of local/regional control (LRC) 1 year after beginning treatment
研究概览
简要总结
This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.
详细描述
Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.
The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.
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
- •Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
- •Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
- •Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.
- •Other serious illnesses or medical conditions including but not limited to:
- •Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •History of significant neurologic or psychiatric disorders including dementia or seizures.
- •Active uncontrolled infection.
- •Active peptic ulcer.
- •Hypercalcemia.
- •Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
- •Patients requiring intravenous alimentation.
- •Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
- •Concurrent treatment with any other anticancer therapy.
- •Participation in an investigational trial within 30 days of study entry.
- •Previous treatment with any biologic therapy is not permitted.
研究组 & 干预措施
Arm A Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
- Subcutaneous daily amifostine at a dose of 500 mg
干预措施: Amifostine (Drug)
Arm A Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
- Subcutaneous daily amifostine at a dose of 500 mg
干预措施: Carboplatin (Drug)
Arm A Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
- Subcutaneous daily amifostine at a dose of 500 mg
干预措施: Paclitaxel (Drug)
Arm A Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
- Subcutaneous daily amifostine at a dose of 500 mg
干预措施: radiation (Radiation)
Arm B No-Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
干预措施: Carboplatin (Drug)
Arm B No-Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
干预措施: Paclitaxel (Drug)
Arm B No-Amifostine
Patients with newly diagnosed, locally advanced stage ill or IV SCCHN
- 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
干预措施: radiation (Radiation)
结局指标
主要结局
Rate of local/regional control (LRC) 1 year after beginning treatment
时间窗: One year after beginning of treatment
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
时间窗: 3, 6 Months
Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
时间窗: End of Radiotherapy
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment
时间窗: 8,12, 24 and 52 weeks
次要结局
- Proportion of patients with PEG dependency(3, 6, and 12 months after completion of study treatment)
- Time to disease progression(baseline to disease progression)
- Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey(baseline, 8, 12, 24, and 52 weeks after completion of study treatment)
- Swallowing function(2 years Post treatment)
- Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment(8, 12, 24, and 52 weeks)
- LRC and overall survival at 2 years after completion of study treatment(2 Years after completion of study treatment)
研究者
Robert I. Haddad, MD
Haddad, Robert I.,M.D.
Dana-Farber Cancer Institute