A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Advanced Laryngeal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- toxicities
研究概览
简要总结
single-modality phase I dose escalation toxicity study for first-line curative treatment of head and neck squamous cell carcinoma.
详细描述
HYDRA will consist of 5 fraction SBRT treatment targeting only grossly evident disease localized by examination and standard diagnostic CT, MR, and PET-CT imaging. Prophylactic coverage of uninvolved at-risk mucosal and nodal drainage basins will be strictly disallowed. The initial dose cohort will be treated to a total of 42.5 Gy in five equal fractions delivered every other day over a two week period (biologically equivalent to 66 Gy delivered in 2 Gy daily fractions), drawn from our successful institutional experience with similar dosing and fractionation for early-stage larynx SBRT. Escalation of total dose will proceed in 2.5 Gy increments, up to a final target dose of 50 Gy.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
- •Stage T1-2N1-2c/T3-4N0-2c disease, as defined by American Joint Committee on Cancer (AJCC) criteria.
- •ECOG (Zubrod) performance status 0-
- •Must be functionally and technically fit for partial laryngectomy.
- •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, for the duration of study participation, and for 90 days following completion of therapy.
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients who have undergone resection of primary disease.
- •Patients who have received induction chemotherapy for their cancer diagnosis.
- •Patients who have undergone a diverting tracheostomy which is either a) traversing directly through tumor, b) has been placed for true airway insufficiency. Patients with a tracheostomy placed preemptively for impending airway compromise remain eligible for enrollment.
- •Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
- •Prior radiation therapy to the head and neck region.
- •Women of childbearing potential (a woman of child-bearing potential is a reproductively mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
- •Patients unable or unwilling to give written, informed consent.
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
- •Transmural myocardial infarction within the last 6 months.
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- •Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. Protocol-specific requirements may also exclude immuno-compromised patients.
- •History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
- •Evidence of metastatic disease
研究组 & 干预措施
Radiation
Patients in each dose cohort will all be treated as a single group. The starting dose will be 8.5 Gy per fraction for 5 fractions (total dose = 42.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per fraction.
干预措施: radiation (Radiation)
结局指标
主要结局
toxicities
时间窗: 90 days
Number of participants with acute related serious adverse events
次要结局
- adverse events(2 years)
- quality of life(5 years)
- dosimetric improvement(2 weeks)
- disease control(5 years)