Removing the Planning Tumor Volume From Radiation Therapy for the Treatment of Head and Neck Squamous Cell Carcinoma
Pilot Study of the Elimination of Planning Tumor Volume (PTV) in Head and Neck Squamous Cell Carcinoma (HNSCC)
This clinical trial studies the side effects and how well removing the planning tumor volume (PTV) from radiation therapy (RT) works in treating patients with head and neck squamous cell carcinoma (HNSCC). Standard therapy for HNSCC often involves giving RT with chemotherapy; however, this approach is associated with a high level of short- and long-term side effects. RT uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. RT is planned to be delivered based on three volumes of the tumor. The first is the gross tumor volume which is the area of the tumor that can be seen, felt, or measured on imaging. The second is the clinical tumor volume which includes the gross tumor volume as well as area beyond this to account for disease that cannot be seen on imaging and may have spread. The third is the PTV which includes an area beyond both the gross tumor volume and clinical tumor volume to account for errors that may happen during RT, such as setup error or movement. As the area between the clinical tumor volume and PTV is not cancer and current advances in RT have improved RT accuracy, researchers think that removing PTV from RT may lower side effects while still being an effective treatment. Removing the PTV from RT may safe, tolerable, and/or effective in treating patients with HNSCC.
Обзор исследования
Статус
Статус
Условия
Условия
- Плоскоклеточный рак головы и шеи
- Ротоглоточный плоскоклеточный рак
- Клиническая стадия III, опосредованная ВПЧ (p16-положительная) карцинома ротоглотки AJCC v8
- Гипофарингеальная карцинома III стадии AJCC v8
- Рак гортани III стадии AJCC v8
- Стадия III Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Гипофарингеальная плоскоклеточная карцинома
- Плоскоклеточный рак гортани
- Клиническая стадия I ВПЧ-опосредованная (p16-положительная) карцинома ротоглотки AJCC v8
- Клиническая стадия II ВПЧ-опосредованная (p16-положительная) орофарингеальная карцинома AJCC v8
- Стадия IVA Гипофарингеальная карцинома AJCC v8
- Стадия IVA Рак гортани AJCC v8
- Стадия IVA Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Стадия IVB Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Гипофарингеальная карцинома I стадии AJCC v8
- Гипофарингеальная карцинома II стадии AJCC v8
- Стадия II рака гортани AJCC v8
- Стадия II Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Стадия I рака гортани AJCC v8
- Стадия 0 Ротоглоточный рак (p16-негативный) AJCC v8
- Ротоглоточный рак I стадии (p16-негативный) AJCC v8
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
PRIMARY OBJECTIVES:
I. Describe the effect of eliminating PTV on locoregional control and marginal recurrence at 6 months in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
II. Describe the effect of PTV on early toxicity, PRO (patient reported outcomes) and QOL (quality of life) in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
SECONDARY OBJECTIVES:
I. Describe the effect of eliminating PTV on locoregional control at 2 and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
II. Describe the patterns of failure when eliminating PTV at 3 months, 2 years and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
III. Describe the effect of eliminating PTV on later toxicity in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
IV. Describe the effect of eliminating PTV on later PRO (patient reported outcomes) and QOL (quality of life) in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
V. Describe differences in dosimetric comparison plans with and without PTV in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
VI. Describe the effect of eliminating PTV on marginal recurrence rate at 2 and 5 years in patients with HNSCC undergoing definitive RT, with or without chemotherapy.
OUTLINE:
Patients undergo intensity-modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) without PTV 5-6 times a week for thirty-five treatment fractions over 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent chemotherapy on study. Additionally, patients undergo computed tomography (CT), fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT, and laryngopharyngoscopy during screening and CT or FDG-PET/CT during follow up.
After completion of study treatment, patients are followed up every 3 months during years 1-2 and then every 6 months during years 3-5.
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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California
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Duarte, California, Соединенные Штаты, 91010
- City of Hope Medical Center
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Главный следователь:
- Arya Amini
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Контакт:
- Arya Amini
- Номер телефона: 626-218-2247
- Электронная почта: aamini@coh.org
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-
Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
-
Documented informed consent of the participant and/or Legally Authorized Representative
- Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
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Age: ≥ 18 years
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Eastern Cooperative Oncology Group (ECOG) ≤ 2
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Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), larynx and hypopharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
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No metastatic disease and eligible for definitive radiation based on the following diagnostic workup:
- General history and physical examination within 56 days prior to registration
- Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration
- FDG -PET/CT (with or without contrast) within 60 days prior to registration
- Diagnostic CT scan of neck (with contrast and of diagnostic quality) within 60 days prior to registration
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Planning to undergo definitive radiation (with or without chemotherapy)
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Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
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Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Exclusion Criteria:
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Recurrent disease
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T1-T2 glottic cancers
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Definitive clinical or radiologic evidence of metastatic diseases
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Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
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Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. Patients with unknown primary or resected primary are eligible if gross nodal disease is present
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Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
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Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
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Severe, active co-morbidity defined as follows:
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Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
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Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
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Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
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Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients
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For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Hepatitis B testing is not required for entry into this protocol
- Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
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Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment for the hepatitis, they are eligible if they have an undetectable HCV viral load. Hepatitis C testing is not required for entry into this protocol
- Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
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Clinically significant uncontrolled illness
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Females only: Pregnant or breastfeeding
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Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
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Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
|
Экспериментальный: Treatment (RT without PTV)
Patients undergo IMRT or IGRT without PTV 5-6 times a week for thirty-five treatment fractions over 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive concurrent chemotherapy on study. Additionally, patients undergo CT, FDG-PET/CT, and laryngopharyngoscopy during screening and CT or FDG-PET/CT during follow up. |
Ancillary studies Given concurrent chemotherapy
Другие имена:
Undergo CT and/or FDG-PET/CT
Другие имена:
Undergo laryngopharyngoscopy
Другие имена:
Undergo FDG-PET/CT
Другие имена:
Undergo IGRT without PTV
Другие имена:
Undergo IMRT without PTV
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percent of patients experiencing locoregional recurrence and marginal recurrence
Временное ограничение: At 6 months post-radiation therapy
|
Will be summarized using descriptive statistics. Will be calculated using the number of patients local or regional recurrence and marginal recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to locoregional recurrence will be measured from completion of radiation therapy to the first documented local or regional recurrence. The cumulative incidence of locoregional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of locoregional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported. |
At 6 months post-radiation therapy
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Incidence of treatment-related adverse events
Временное ограничение: From start of treatment to three months post-radiation therapy
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As assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution. |
From start of treatment to three months post-radiation therapy
|
|
Change in Functional Assessment of Cancer Therapy Head and Neck Questionnaire (FACT-H&N) v4.0 scores
Временное ограничение: From baseline to end of treatment and 3 months post-radiation therapy
|
At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses. |
From baseline to end of treatment and 3 months post-radiation therapy
|
|
Change in Eastern Cooperative Oncology Group (ECOG) performance status
Временное ограничение: From baseline to end of treatment and 3 months post-radiation therapy
|
At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses. |
From baseline to end of treatment and 3 months post-radiation therapy
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Locoregional recurrence rate
Временное ограничение: At 2 and 5 years post-radiation therapy
|
Will be summarized using descriptive statistics. Will be calculated using the number of patients local or regional recurrence and marginal recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to locoregional recurrence will be measured from completion of radiation therapy to the first documented local or regional recurrence. The cumulative incidence of locoregional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of locoregional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported. |
At 2 and 5 years post-radiation therapy
|
|
Local recurrence rates
Временное ограничение: At 3 months, 2 years, and 5 years post-radiation therapy
|
Will be summarized using descriptive statistics. Will be calculated using the number of patients local recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to local recurrence will be measured from completion of radiation therapy to the first documented local recurrence. The cumulative incidence of local recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of local recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported. |
At 3 months, 2 years, and 5 years post-radiation therapy
|
|
Regional recurrence rates
Временное ограничение: At 3 months, 2 years, and 5 years post-radiation therapy
|
Will be summarized using descriptive statistics. Will be calculated using the number of patients regional recurrence divided by the total number of treated/evaluable subjects. Point estimates and two-sided 95% exact binomial confidence intervals will be reported. As secondary analyses, time to regional recurrence will be measured from completion of radiation therapy to the first documented regional recurrence. The cumulative incidence of regional recurrence at 3 months, 2 years, and 5 years will be estimated. Patients alive and free of regional recurrence will be censored at the date of their last contact. Point estimates and two-sided 95% confidence intervals will be reported. |
At 3 months, 2 years, and 5 years post-radiation therapy
|
|
Incidence of treatment-related adverse events
Временное ограничение: From start of treatment to 1 year post-radiation therapy
|
As assessed by CTCAE v6.0, delineated by grade and attribution. Observed toxicities will be summarized by incidence, type, severity, and attribution. |
From start of treatment to 1 year post-radiation therapy
|
|
Change in FACT-H&N v4.0 scores
Временное ограничение: From baseline to 6, 9, and 12 months post-radiation therapy
|
At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses. |
From baseline to 6, 9, and 12 months post-radiation therapy
|
|
Change in ECOG performance status
Временное ограничение: From baseline to 6, 9, and 12 months post-radiation therapy
|
At each post-baseline time point, the observed score and change from baseline will be summarized using descriptive statistics, together with the mean change and its two-sided 95% confidence interval. The number of patients with available assessments will be reported at each time point. (Generalized) linear mixed-effects models may be used to characterize changes over time for exploratory analyses. |
From baseline to 6, 9, and 12 months post-radiation therapy
|
|
Prespecified dosimetric parameters for organs at risk
Временное ограничение: At time of radiation therapy (Up to 6-7 weeks)
|
Will be summarized separately for the delivered plan without planning tumor volume (PTV) and the comparison plan generated using PTV. Because both plans are generated for the same patient, the dosimetric quantity will be the within-patient difference between plans. Any formal paired comparisons will be considered exploratory. |
At time of radiation therapy (Up to 6-7 weeks)
|
Соавторы и исследователи
Спонсор
Спонсор
Соавторы
Соавторы
Следователи
Следователи
- Главный следователь: Arya Amini, City of Hope Medical Center
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Стоматогнатические заболевания
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Новообразования по гистологическому типу
- Новообразования головы и шеи
- Новообразования железистые и эпителиальные
- Новообразования дыхательных путей
- Оториноларингологические заболевания
- Новообразования глотки
- Оториноларингологические новообразования
- Заболевания глотки
- Карцинома, плоскоклеточный рак
- Заболевания гортани
- Плоскоклеточный рак головы и шеи
- Карцинома
- Новообразования гортани
- Новообразования ротоглотки
- Гипофарингеальные новообразования
- Терапия
- Диагностические методы и процедуры
- Диагноз
- Хирургические процедуры, оперативные
- Минимально инвазивные хирургические процедуры
- Диагностические методы, хирургический
- Лучевая терапия
- Лучевая терапия, конформная
- Лучевая терапия, компьютерная помощь
- Лекарственная терапия
- Эндоскопия
- Лучевая терапия, модулированная интенсивностью
- Лучевая терапия, с изображением
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- 25155
- P30CA033572 (Грант/контракт NIH США)
- NCI-2026-07861 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
- 25155 (Другой идентификатор: City of Hope Medical Center)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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