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Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

2017年12月3日 更新者：Masonic Cancer Center, University of Minnesota

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

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.

研究概览

地位

终止

条件

干预/治疗

详细说明

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.

Tertiary

  • Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
  • Evaluate the quality of saliva by examining total protein concentrations.
  • Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
  • Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
  • Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.

OUTLINE: This is a pilot study.

  • Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
  • Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
  • Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.

Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.

Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

4

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • Masonic Cancer Center at University of Minnesota

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
生物：filgrastim
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
其他名称：
  • 脑脊液
  • 纽普生
生物：pegfilgrastim
If applicable on day 5, repeating every 3 weeks for 2 courses.
其他名称：
  • Neulasta, G-CSF
药品：cisplatin
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
其他名称：
  • CDDP
  • 顺铂
  • 铂醇AQ
  • cis-diamminedichloridoplatinum
药品：docetaxel
Intravenous over 1 hour on day 1.
其他名称：
  • 泰素帝(R)
药品：fluorouracil
Intravenous continuously on days 1-4.
其他名称：
  • 5-氟尿嘧啶
  • 阿杜西尔
程序：conventional surgery
As appropriate, neck dissection.
其他名称：
  • 手术
辐射：radiation therapy
60 Gy 5 days/week x 6 weeks with cisplatin
其他名称：
  • 辐射

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Patients With Feeding Tube Dependency
大体时间：at 12 months
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
at 12 months

次要结果测量

结果测量
措施说明
大体时间
Number of Days With Progression-free Survival
大体时间：Between date of registration to date of first treatment failure or death.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Between date of registration to date of first treatment failure or death.
Number of Days - Overall Survival
大体时间：Between date of registration to date of death.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Between date of registration to date of death.
Number of Days With Disease Free Survival
大体时间：From Date of Registration to Date of First Treatment Failure or Death
All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
From Date of Registration to Date of First Treatment Failure or Death
Time to Treatment Failure
大体时间：Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
Swallowing Ability - Quality of Life Scores
大体时间：Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
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
大体时间：baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Masonic Cancer Center, University of Minnesota

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Frank G. Ondrey, MD, PhD、Masonic Cancer Center, University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年3月1日

初级完成 (实际的)

2008年4月1日

研究完成 (实际的)

2008年4月1日

研究注册日期

首次提交

2006年7月13日

首先提交符合 QC 标准的

2006年7月13日

首次发布 (估计)

2006年7月14日

研究记录更新

最后更新发布 (实际的)

2017年12月28日

上次提交的符合 QC 标准的更新

2017年12月3日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2005LS012
  • UMN-0502M67486

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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