Biomarker-Driven Radiation Dose Reduction After TORS in Patients With HPV-Positive Oropharyngeal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Swallowing Function T-Test
研究概览
简要总结
This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate swallow function among post-operative circulating tumor HPV deoxyribonucleic acid (ctHPVDNA)-negative patients treated with reduced intensity adjuvant radiation therapy (RT) doses as compared to historical controls from ECOG 3311.
SECONDARY OBJECTIVES:
I. Evaluate progression free survival (PFS), overall survival (OS), and locoreginal control (LRC) among post-operative ctHPVDNA-negative patients treated with reduced adjuvant RT doses.
II. Evaluate PFS among post-operative ctHPVDNA-positive patients treated with standard of care adjuvant therapy.
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
- •Age >= 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%).
- •Life expectancy > 12 weeks as determined by the Investigator.
- •Has diagnosis of HPV-associated squamous cell carcinoma of the oropharynx
- •HPV positive either via p16 status or via in situ hybridization
- •This includes patients with HPV positive squamous cell carcinoma of an unknown primary of the head and neck presumed to be of oropharyngeal origin who have undergone ipsilateral palatine and lingual tonsillectomies.
- •pT1-2, pN0-1, cM0 disease.
- •Positive ctHPVDNA titer prior to surgery.
- •=< 10 pack-year smoking history.
- •Completed transoral robotic surgery (TORS) oropharyngectomy and at least ipsilateral neck dissection by an Emory otolaryngologist.
- •Pathology must demonstrate at least one of the follow intermediate risk factors:
- •Close margin (1 - 4 mm)
- •Perineural invasion
- •Lymphovascular space invasion
- •2 - 4 positive lymph nodes without extranodal extension (ENE)
- •A single positive lymph node > 3 cm in size, without ENE
- •Pathology cannot demonstrate > 4 positive lymph nodes, ENE, or a positive final margin (defined as < 1 mm). Margins that have been subsequently cleared are allowed.
- •Radiation increases the risk of birth defects. For this reason, females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy.
- •FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of radiation. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.
- •Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
- •Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
排除标准
- •Patients with a prior history of malignancy in the last two years (excluding non- melanomatous skin cancer).
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1).
- •Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.
- •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.
- •Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade >= 3 hypertension (diastolic blood pressure >= 100 mmHg or systolic blood pressure >= 160 mmHg) despite antihypertensive therapy.
结局指标
主要结局
Swallowing Function T-Test
时间窗: At 1 year post surgery
A one-sample t-test will be conducted to compare the 1-year MDADI composite score with the null value of 79.1.
Swallowing Function Mean
时间窗: At 1 year post surgery
Will be assessed by the MD Anderson Dysphagia Index (MDADI) composite score (range 20 - 100, higher is better). Mean MDADI composite score will be reported at one year, along with a 95% confidence interval for the mean.
次要结局
- Locoregional Control (LRC)- Six Month(At 6 months)
- Locoregional Control (LRC)- Two Year(At 2 years)
- Overall Survival (OS)(From study entry to death due to any cause, assessed up to 24 months)
- Quality of Life (QoL) - Michigan Xerostomia(At 2 years)
- Quality of Life (QoL) - European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L)(At 2 years)
- Progression-Free Survival (PFS)(From study entry to the earliest disease progression or death from any cause, assessed up to 24 months)
- Quality of Life (QoL) - MD Anderson Symptom Inventory(At 2 years)
研究者
James Bates
Principal Investigator
Emory University