Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
研究概览
简要总结
This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. To compare the 2-year rate of Common Terminology Criteria for Adverse Events (CTCAE)-4.0 grade 3 or higher toxicity at 2 years between the two treatment arms.
SECONDARY OBJECTIVES:
I. To compare the 2-year locoregional failure free survival (LFFS) in patients being treated with reirradiation with either stereotactic ablative radiotherapy (SBRT) versus intensity modulated radiation therapy/intensity modulated proton therapy (IMRT/IMPT).
II. To determine if there is any difference in local control, progression-free survival, and overall survival between the two arms.
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
- •Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
- •Not eligible for surgery for recurrence or poor surgical candidate
- •Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
- •1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
- •Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
- •Negative pregnancy test for women of child bearing potential
排除标准
- •Patients who are pregnant or breast feeding
- •Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- •a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- •b) No myocardial infarction within 3 months of registration
- •Widely metastatic disease (oligometastatic disease acceptable)
研究组 & 干预措施
Group I (SBRT)
Patients undergo SBRT every other day for a total of 5 treatments.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Group II (IMRT/IMPT)
Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Group II (IMRT/IMPT)
Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
干预措施: Proton Radiation (Radiation)
结局指标
主要结局
Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
时间窗: At 2 years
Will use the methods of Gooley et al. to estimate the cumulative incidence of Tox3+, as well as competing-risk regression to model cumulative incidence of Tox3+ while treating death not related to Tox3+ as a competing event. The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
次要结局
- Local failure free survival (LFFS) defined as failure (recurrence or progression) within the prescribed radiation field, including failure within 2 cm of the radiation field(From treatment initiation until local failure or death from any cause, assessed at 2 years)
- Incidence of late grade 3 or higher toxicity assessed by CTCAE(90 days up to 2 years)
- Local control defined as absence of local failure(Up to 2 years)
- Incidence of acute grade 3 or higher toxicity assessed by CTCAE(Up to 90 days after completion of radiation therapy)
- Overall survival(From treatment initiation until time to death from any cause, assessed up to 2 years)
- Patient reported outcomes (PROs)(Up to 2 years)
- Progression free survival (PFS)(From treatment initiation until an LFFS event, or occurrence, recurrence, or progression of distant metastases, whichever occurs first, assessed up to 2 years)