Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of Participants With a Recurrence in the Unirradiated Neck(s)
研究概览
简要总结
The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx .
- •Treated with surgical resection with one (or both) side(s) of the neck pathologically N
- •Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics:
- •Close margin (<= 0.5 cm)
- •Positive margin
- •Perineural invasion
- •Lymphovascular space invasion
- •Metastatic disease in more than one lymph node
- •Metastatic disease in more than one lymph node group
- •Extracapsular extension in any lymph node
- •Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion.
- •Patients must sign study specific, Institutional Review Board (IRB)-approved consent form.
排除标准
- •Previous head and neck cancer other than non melanoma skin cancer.
- •Previous head and neck surgery.
- •Female patients who are pregnant or nursing.
研究组 & 干预措施
Intensity modulated radiation therapy (IMRT)
-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
干预措施: Intensity modulated radiation therapy (Radiation)
结局指标
主要结局
Number of Participants With a Recurrence in the Unirradiated Neck(s)
时间窗: 12 months of follow-up
* Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. * Recurrence is defined as the return of cancer after treatment * Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.
次要结局
- Quality of Life (QOL) as Measured by Xerostomia QOL Data(Median follow-up was 22 months)
- Kaplan Meier Estimate of Locoregional Recurrence Free Survival(3 years)
- Disease Specific Survival Rate(Completion of follow-up (minimum of 5 years from completion of treatment))
- Kaplan Meier Estimate of Overall Survival(3 years)
- Quality of Life (QOL) as Measured by Overall Global QOL Scores(Median follow-up was 22 months)
- Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms(Completion of follow-up (minimum of 5 years from completion of treatment))
- Patterns of Failure Associated With Implementation of Primary Objective(Completion of follow-up (minimum of 5 years from completion of treatment))