NCT03548285已完成不适用
A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers
研究概览
简要总结
This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.
详细描述
SBRT treatment will be delivered to patients diagnosed with stage I-II glottic larynx cancer twice per week for 5 fractions (42.5 Gy cohort, low-risk) or daily for 16 fractions (58.08 Gy cohort, moderate-risk).
Low-risk is defined by:
- Planning target volume (PTV) less than 10 cc, AND
- No reported smoking within 1 month from registration
Moderate-risk is defined by:
- Planning target volume (PTV) greater than or equal to 10 cc, OR
- Smoking within 1 month from registration (no more than 1 pack per day)
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
- •Clinical stage I-II (American Joint Committee on Cancer AJCC, 7th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
- •Age ≥ 18 years.
- •ECOG Performance Status 0-2
- •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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
- •Ability to understand and the willingness to sign a written informed consent.
- •Patients with cognitive impairment or other limited decision making capacity with the ability to understand and willingly sign written informed consent or have the consent signed by a designated legally authorized representative (LAR)
排除标准
- •AJCC stage III or stage IV larynx cancer
- •Involvement of the arytenoid cartilage beyond the vocal process.
- •Prior chemotherapy for treatment of the targeted larynx lesion
- •Synchronous primaries in the head and neck
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- •Subjects smoking in excess of 1 pack of cigarettes per day.
- •Subjects may not be receiving any other investigational agents.
- •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.
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
研究组 & 干预措施
SBRT Treatment
Experimental
Patients are all treated with stereotactic body radiation therapy (SBRT), using either CyberKnife or volumetric modulated arc therapy (VMAT). Dosing is based on the patients' assessed risk. The two cohorts are low risk and moderate risk.
Low-risk is defined by:
- Planning target volume (PTV) less than 10 cc, AND
- No reported smoking within 1 month from registration
Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)- this provides both an adequate tumoricidal dose, and a limited dose to normal tissue.
Moderate-risk is defined by:
- Planning target volume (PTV) greater than or equal to 10 cc, OR
- Smoking within 1 month from registration (no more than 1 pack per day)
Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy)
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers
时间窗: 2 years
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
次要结局
- Voice-quality Score Following Treatment With SABR(From baseline to 2 years post-treatment)
- Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR(90 days, 3 years)
- Health-related Quality of Life Following Treatment With SABR.(From baseline to 2 years post-treatment)
- Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk(2 years)
- Overall Survival(2 years)
- Percentage of Patient Population With Regional Failure and Distant Metastasis(2 years)
- Laryngectomy-free Survival(2 years)
研究者
David Sher
Professor
University of Texas Southwestern Medical Center
研究点 (2)
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