HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 174
- 试验地点
- 9
- 主要终点
- Rate of local/regional control (LRF)
研究概览
简要总结
This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the local-regional control among subjects in each arm at 2 years after study registration.
II. To evaluate difference in MD Anderson Dysphagia Inventory (MDADI) score between patients with proton and intensity-modulated radiation therapy (IMRT) adjuvant radiation.
SECONDARY OBJECTIVES:
I. To determine overall survival, progression free survival, local, regional, distant recurrence risks, and infield and outfield recurrence in the trial at 2 years after study registration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age >= 18 years
- •Histological confirmation of a newly diagnosed non-human papillomavirus (HPV) associated malignant epithelial cancer in the head and/or neck. Diagnosis requires confirmation of p16 and/or HPV DNA negativity for oropharyngeal and unknown primary sites. p16 positivity in skin cancers is allowed
- •Primary lesion located in the nasal cavity, paranasal sinuses, oral cavity, oropharynx, larynx, hypopharynx, salivary glands, lymph nodes (unknown primary or metastasis from head and neck [HN]-skin primary) or skin cancer where lymph node radiation is recommended
- •NOTE: Patients with primary lesions in the larynx must have a T3 primary, bulky T2 primary (> 6 cc), and/or at least 1 regional lymph node
- •Confirmation of American Joint Committee on Cancer (AJCC) 8th edition defined M0 established by positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) performance status (0-1 prior to initial treatment)
- •Able to provide written informed consent
- •Able to complete questionnaires independently or with assistance
- •Willing to return to enrolling institution for follow up during the observation phase
排除标准
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- •NOTE: Patients known to be HIV positive, but without clinical evidence of immunocompromised state, are eligible for this trial
- •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
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •Other active malignancy =< 2 years prior to registration
- •EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix and prostate cancer with a Gleason score of 6 or less
- •NOTE: If there is a history or prior malignancy, they must not be receiving ongoing anticancer treatment
- •History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •Prior radiation therapy that would have a clinically significant overlap with the intended head/neck radiation
- •For Arms A and B only: Unable to receive proton therapy because of extensive metallic hardware in close proximity to treatment site, logistical circumstances, or any other reason
- •Any of the following diagnoses: HPV-associated squamous cell carcinoma, germ cell tumors, hematologic malignancies, neuroendocrine malignancies, adenoid cystic carcinoma, sarcomas of bone, benign tumors
研究组 & 干预措施
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Intensity-Modulated Proton Therapy (Procedure)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Positron Emission Tomography (Procedure)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Computed Tomography (Procedure)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Intensity-Modulated Proton Therapy (Procedure)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Computed Tomography (Procedure)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Positron Emission Tomography (Procedure)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Computed Tomography (Procedure)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Positron Emission Tomography (Procedure)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm A (IMPT, IMRT, cisplatin)
Patients undergo IMPT or IMRT for 18 sessions over 24 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Cisplatin (Drug)
Arm B (IMPT, cisplatin)
Patients undergo IMPT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Cisplatin (Drug)
Arm C (IMRT, cisplatin)
Patients undergo IMRT for 15 sessions over 19 days in the absence of disease progression or unacceptable toxicity. Patients may receive cisplatin IV over 1-2 hours per standard of care. Patients undergo CT or MRI and PET/CT or PET/MRI during screening and follow-up. Patients may also undergo blood sample collection throughout the trial.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Rate of local/regional control (LRF)
时间窗: At 2 years
The 2-year LRF rate will be estimated by counting the number of patients with a local or regional failure and dividing by the total number of eligible patients.
次要结局
- Quality of life (QOL) and financial burden - MDADI(Up to 5 years)
- Quality of life (QOL) and financial burden - EQ-5D-5L(Up to 5 years)
- Quality of life (QOL) and financial burden - OMWQ-HN(Up to 5 years)
- Regional recurrence rates(Up to 5 years)
- Local recurrence incidence(Up to 5 years)
- Distant recurrence rates(Up to 5 years)
- Invasive disease-free survival (DFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
- Incidence of secondary acute effects attributable to radiation therapy(Up to 3 months after completion of radiation therapy)
- Incidence of late adverse events(Up to 3 years after completion of radiation therapy)
- Incidence of acute adverse events(Up to 3 months after radiation therapy)