Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Официальное название

The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma

Обзор

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.

Подробное описание

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.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Вмешательства

• Другое Immunotherapy
  All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
• Другое Quality-of-Life Assessment
  Ancillary studies
• Лучевая терапия Radiation Therapy
  Undergo nodal radiation therapy

Первичные конечные точки

• Time to regional nodal recurrence [Срок оценки: From date of sentinel lymph node biopsy, assessed up to 5 years]

Вторичные конечные точки (6)

• Time to locoregional recurrence [Срок оценки: From date of sentinel lymph node biopsy, assessed up to 5 years]
• Time to distant metastasis [Срок оценки: From date of sentinel lymph node biopsy, assessed up to 5 years]
• Progression-free survival [Срок оценки: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years]
• Overall survival [Срок оценки: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years]
• Incidence of long term toxicity [Срок оценки: Up to 5 years]
• Patient reported quality of life [Срок оценки: At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Baptist - MD Anderson Cancer Center — Jacksonville
• Cooper Hospital UNIV MED CTR. — Camden
• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04594187 · 2020-0148 · NCI-2020-06904 · 2020-0148

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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