Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure. This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.
详细描述
Primary Objectives
To determine whether:
1. Omission of the contralateral neck cancer treatment is safe and toxicity-sparing for participants with well lateralized oropharyngeal HNSCC undergoing definitive or PORT radiation. This will be demonstrated by acceptably low contralateral neck failures (<15%)
Secondary Objectives
To determine:
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
- •Newly diagnosed histopathologically-proven p16+ and/or HPV+ HNSCC of the base of tongue or faucial tonsil
- •cT1-2N0-1 per AJCC 8th edition staging.
- •Tumor does not cross midline, and must be >1cm from midline
- •For tonsil tumors, the primary may extend onto the palate or into the BOT but still be >1cm from midline
- •No evidence of contralateral neck disease on contrast MRI, CT Head/Neck, PET/CT, or lymphoscintigraphy nor retropharyngeal lymphadenopathy.
- •Able to undergo lymphoscintigraphy procedure
- •No contraindications for SLNM, adjuvant chemotherapy, RT nor adjuvant/definitive radiotherapy.
- •Age >18 years
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Previous HN Cancer except small skin cancers.
- •Any retropharyngeal lymphadenopathy on either MRI, CT, or PET/CT
- •Contralateral neck nodal disease radiographically detected per routine diagnostic imaging or SPECT-CT.
- •Distant metastatic spread at the time of inclusion
- •Chemotherapy or surgery (for the present tumor), prior to inclusion.
- •Previous radiation treatment in the head and neck region, for any reason, except for cutaneous lesions that would not lead to overlap with definitive bilateral neck irradiation
- •Recurrent or second primary tumor in the head and neck region
- •Non-tongue base or non-faucial tonsil primaries
- •Prior history of regionally advanced or distant spread cancers
- •Pregnancy or no active contraception for pre-menopausal women
- •Known hypersensitivity to iodine or nanocolloid injection
- •Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
研究组 & 干预措施
Arm 1- Ipsilateral
Participants with ipsilateral-only drainage (Arm 1- Ipsilateral) will be randomized to assign definitive ipsilateral RT (without concurrent chemotherapy) -vs- ipsilateral surgery (TORS/ND).
干预措施: Arm 1- Ipsilateral (Radiation)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点