The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 3
- 主要终点
- Time to regional nodal recurrence
研究概览
简要总结
This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To determine if regional nodal radiation therapy prolongs the time to regional recurrence.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive adjuvant immunotherapy and nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks).
GROUP II: Patients receive adjuvant immunotherapy alone.
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
- •Must be planned for post-operative immunotherapy
- •No evidence of distant metastasis as determined by clinical examination and any form of imaging
- •No evidence of clinically involved lymph nodes prior to SLNB
- •Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension [ECE] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)
- •Has provided written informed consent for participation in this trial
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- •Life expectancy greater than 6 months
- •Patients capable of childbearing are using adequate contraception
- •Available for follow-up
排除标准
- •Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
- •Distant metastasis
- •Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues
- •Women who are pregnant
- •Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
研究组 & 干预措施
Group I (immunotherapy, radiation therapy)
Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.
干预措施: Immunotherapy (Other)
Group I (immunotherapy, radiation therapy)
Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.
干预措施: Quality-of-Life Assessment (Other)
Group I (immunotherapy, radiation therapy)
Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.
干预措施: Radiation Therapy (Radiation)
Group II (immunotherapy)
Patients planned to undergo immunotherapy.
干预措施: Immunotherapy (Other)
Group II (immunotherapy)
Patients planned to undergo immunotherapy.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Time to regional nodal recurrence
时间窗: From date of sentinel lymph node biopsy, assessed up to 5 years
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up
次要结局
- Time to locoregional recurrence(From date of sentinel lymph node biopsy, assessed up to 5 years)
- Overall survival(From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years)
- Progression-free survival(From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years)
- Incidence of long term toxicity(Up to 5 years)
- Patient reported quality of life(At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy)
- Time to distant metastasis(From date of sentinel lymph node biopsy, assessed up to 5 years)