Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Patients With Feeding Tube Dependency
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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
详细描述
OBJECTIVES:
Primary
- Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
Secondary
- Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
- Determine the pattern of failure in patients treated with this regimen.
- Evaluate the quality of life of patients treated with this regimen.
- Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of the head and neck
- •Stage IVA or IVB disease
- •Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
- •Measurable or evaluable disease
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
- •Bilirubin normal
- •Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
- •AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- •AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- •AP ≤ 5 times ULN AND AST or ALT normal
排除标准
- •Salivary gland, sinus, or nasopharyngeal primary disease
- •Evidence of distant metastatic disease
- •Pregnant or nursing
- •Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
- •Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
- •Peripheral neuropathy ≥ grade 2
- •Hearing loss ≥ grade 2
- •Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
- •Poor nutritional status, in the opinion of the investigator
- •Active infection
- •Active ischemic heart disease
- •Myocardial infarction within the past 6 months
- •Prior radiotherapy above the clavicles
- •Prior chemotherapy
- •Prior surgery to the primary tumor except biopsy
- •Concurrent amifostine or other investigational agents
研究组 & 干预措施
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: filgrastim (Biological)
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: pegfilgrastim (Biological)
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: cisplatin (Drug)
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: docetaxel (Drug)
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: fluorouracil (Drug)
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: conventional surgery (Procedure)
Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Number of Patients With Feeding Tube Dependency
时间窗: at 12 months
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
次要结局
- Number of Days With Progression-free Survival(Between date of registration to date of first treatment failure or death.)
- Number of Days - Overall Survival(Between date of registration to date of death.)
- Number of Days With Disease Free Survival(From Date of Registration to Date of First Treatment Failure or Death)
- Time to Treatment Failure(Number of Days from Complete or Partial Response to First Date of Recurrence or Progression)
- Swallowing Ability - Quality of Life Scores(Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.)
- Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire(baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year)