A Phase II Study of Docetaxel, Carboplatin With and Without Low Dose Radiation as Induction Therapy in Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary Site Complete Response Rate
研究概览
简要总结
The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.
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
- Single (Participant)
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 or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B and select Stage II tumors of the BOT who are appropriate for potentially curative therapy with chemoradiotherapy.
- •Measurable disease.
- •ECOG performance status of 0, 1 or 2
- •No prior chemotherapy for the current locally advanced SCCHN.
- •Age ≥18 years.
- •Life expectancy of greater than 3 months
- •Normal organ and marrow function measured within 14 days of registration as defined below:
- •absolute neutrophil count ≥ 1,000/mcL
- •platelets ≥ 100,000/mcL
- •total bilirubin < institutional upper limit of normal
- •AST(SGOT ≤ 2.5 × institutional upper limit of normal
- •Alkaline phosphatase ≤ 2.5 × institutional upper limit of normal
- •creatinine within normal institutional limits
- •o Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior chemotherapy for SCCHN
- •Patients who are receiving any other investigational agents.
- •Patients with known brain metastases
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Carboplatin or Docetaxel.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women
- •HIV-positive patients on combination antiretroviral therapy
- •Other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 years.
- •Patients with nasopharynx or salivary gland primary site
- •Patients with distant metastatic disease (M1c)
- •Patients with grade II or greater peripheral neuropathy
研究组 & 干预措施
Chemotherapy plus Radiation Therapy
Low dose fractionated radiation - 80cGy with chemotherapy
干预措施: Low dose fractionated radiation - 80cGy with chemotherapy (Radiation)
Chemotherapy without Radiation
Chemotherapy only
干预措施: Docetaxel and Carboplatin AUC 6 (Drug)
结局指标
主要结局
Primary Site Complete Response Rate
时间窗: Up to 50 days
Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.
次要结局
- Overall Response Rate(Up to 50 days)
- Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.(Up to 50 days (pre- and post-treatment))
- 3-year Overall Survival(From date of randomization until date of death from any cause, assessed up to 3 years)
研究者
Susanne Arnold
Principal Investigator
University of Kentucky