Phase I Safety Assessment of Hypofractionated Postoperative Radiotherapy (H-PORT) for Intermediate-Risk Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial.
SECONDARY OBJECTIVES:
I. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion.
II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck (oral cavity, oropharynx or larynx); Note: Hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications.
- •Clinical stage I-IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
- •General history and physical examination prior to registration;
- •Chest X-ray (at a minimum) or chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) prior to registration.
- •Total resection of the patient's cancer (i.e. no residual disease after total resection of the patient's cancer).
- •One or more indications for postoperative radiotherapy, based upon pathologic findings:
- •Perineural invasion;
- •Lymphovascular invasion;
- •Single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular Extension);
- •Close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin);
- •Pathologically confirmed T3 or T4a primary tumor;
- •T2 oral cavity cancer with ≥ 5 mm depth of invasion.
- •Zubrod Performance Status 0-
- •Negative pregnancy test within 14 days prior to registration for participants who may become pregnant.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial.
- •The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
排除标准
- •Recurrence of the study cancer.
- •History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
- •Pregnancy and individuals unwilling to discontinue nursing.
- •Reliant on a feeding tube (gastric or jejuno) to maintain adequate nutrition at the time of registration
- •Anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed.
- •Per the operative and/or pathology report, positive margin(s) [defined as tumor present at the cut or inked edge of the tumor], nodal extracapsular extension, and/or gross residual disease after surgery; Note: Patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: From the start of H-PORT up 12 months post-radiation
All grades are based on Common Terminology Criteria for Adverse Events (CTCAE v.5). H-PORT in this population will be deemed safe if 0-2 patients out of the first 12 evaluable patients experience DLTs. Should 3 or more patients experience DLTs at any time point during the DLT evaluation period, then accrual to the trial will be stopped, if applicable. Once 12 evaluable eligible patients have completed their DLT assessment, the rate of unacceptable DLTs and 95% confidence interval will be summarized using proportions for binary outcomes and the exact binomial method.
次要结局
- Rate of radiation discontinuations(From the start to the end of H-PORT, assessed up to 4 weeks)
- Incidence of Adverse Events(From the start of H-PORT up to 12 months post-radiation)
- Rate of radiation interruptions(From the start to the end of H-PORT, assessed up to 4 weeks)