Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study
研究概览
简要总结
The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.
This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational.
Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
Baseline Visit:
If you are found to be eligible to take part in this study and agree, you will have a baseline visit. The following tests and procedures will be performed:
- You will have a hearing test.
- You will have a dental exam. During this exam, your saliva flow will be measured and you will be checked for lockjaw.
- Your swallowing function will be tested with a special type of x-ray called a modified barium swallow (MBS). During the test, you will eat and drink foods and liquids mixed with a "contrast" chemical called barium that will make your throat more visible in the x-rays. A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat.
- You will complete a questionnaire about swallowing that should take about 5 minutes to complete.
- You will have a video-strobe procedure to check your vocal cords. To perform a video-strobe procedure, a small camera will be inserted into the throat through your nose or mouth. You will be awake for this procedure and the study staff will give you the option of receiving a numbing spray for your nose and/or throat.
- Photos of the inside of your mouth will be taken to check for mouth sores.
- You will fill out questionnaires about your quality of life, work status, medical history, smoking status, and any symptoms you may have. Completing these questionnaires should take about 10-15 minutes.
Study Groups:
If you are among the first 15 patients enrolled in the study, you will be in Group 1.
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
- 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
- •Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
- •Age ≥18 years
- •Clinical stage T1-3, N0-2 (AJCC, 8th ed.), with no distant metastases, based on routine staging workup.
- •Positive for HPV by p16 IHC or ISH
- •Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years.
- •No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- •No retropharyngeal nor level IV (or lower) lymphadenopathy (i.e. nodes in level I-III only)
- •Eastern Cooperative Oncology Group (ECOG) = 0, 1, or
- •Dispositioned to photon/proton radiotherapy +/- chemotherapy
- •For females of child-bearing age, a negative pregnancy test
排除标准
- •Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their HNSCC.
- •Pregnant or breast-feeding females
- •Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- •Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- •Myocardial infarction within 3 months of registration
- •Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.
- •History of claustrophobia
- •Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m2
研究组 & 干预措施
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Modified Barium Swallow (MBS) (Procedure)
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Swallowing Questionnaire (Behavioral)
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Symptom Questionnaire (Behavioral)
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Video-Strobe Procedure (Procedure)
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning (Procedure)
MRI Guided Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Intensity Modulated Radiotherapy (IMRT) (Radiation)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Modified Barium Swallow (MBS) (Procedure)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Swallowing Questionnaire (Behavioral)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Symptom Questionnaire (Behavioral)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Video-Strobe Procedure (Procedure)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning (Procedure)
Standard-of-Care Intensity Modulated Radiotherapy (IMRT)
Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
干预措施: Intensity Modulated Radiotherapy (IMRT) (Radiation)
结局指标
主要结局
Composite Dysphagia Outcome Determined by Trace or Frank Aspiration Seen on Modified Barium Swallow Study
时间窗: 6 months post radiation therapy
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Composite Dysphagia Outcome Determined by Diagnosis of Aspiration Pneumonia
时间窗: 6 months post radiation therapy
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Locoregional Control
时间窗: 6 months post radiation therapy
Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.
Composite Dysphagia Outcome Determined by PEG Tube Dependence at Last Follow-Up
时间窗: 6 months post radiation therapy
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia. These include: 1) PEG tube dependence at last follow-up; 2) trace or frank aspiration seen on modified barium swallow study; 3) diagnosis of aspiration pneumonia; 4) presence of pharyngoesophageal structure on modified barium swallow study or endoscopy with subsequent need for dilation.
Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Modified Barium Swallow Study
时间窗: 6 months post radiation therapy
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Endoscopy with Subsequent Need for Dilation
时间窗: 6 months post radiation therapy
Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.
次要结局
- Physician-Reported Toxicity(Weekly during radiation therapy up to 2 years after radiation therapy)
- Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Dysphagia Inventory (MDADI)(Baseline up to 2 years after radiation therapy)
- Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN(Baseline up to 2 years after radiation therapy)
- Patient Reported Outcome (PRO) Measures of symptoms Using Work Productivity and Activity Impairment Questionnaire(Baseline up to 2 years after radiation therapy)
- Distant Metastasis-Free Survival(Start of treatment up to 5 years)
- Patient Reported Outcome (PRO) Measures of Symptoms Using MD Anderson Symptom Inventory (MDASI)(Baseline up to 2 years after radiation therapy)
- Patient Reported Outcome (PRO) Measures of Symptoms Using Xerostomia and Health Questionnaire (EQ-5D-3L)(Baseline up to 2 years after radiation therapy)
- Overall Survival(Start of treatment up to 5 years)
- Progression-Free Survival(Start of treatment up to 5 years)
- Patient Reported Outcome (PRO) Measures of symptoms Using Performance Status Scale-HN(Baseline up to 2 years after radiation therapy)