Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Description

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.

Conditions

Melanoma

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Study Overview

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Study Details

Study overview

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.

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

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Baptist - MD Anderson Cancer Center, Jacksonville, Florida, United States, 32207

Camden

Cooper Hospital UNIV MED CTR., Camden, New Jersey, United States, 08103

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Devarati Mitra, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-02-24