Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Last updated: December 2, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Melanoma

Treatment

Radiation Therapy

Quality-of-Life Assessment

Immunotherapy

Clinical Study ID

NCT04594187
2020-0148
2020-0148
NCI-2020-06904
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be planned for post-operative immunotherapy

  • No evidence of distant metastasis as determined by clinical examination and any formof imaging

  • No evidence of clinically involved lymph nodes prior to SLNB

  • Pathologically confirmed sentinel lymph node positive melanoma with high riskfeatures (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

Exclusion

Exclusion Criteria:

  • 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 priorRT field would be included in the current treatment field. In other words, treatmenton this trial would require re-irradiation of tissues

  • Women who are pregnant

  • Adults unable to consent, individuals who are not yet adults, pregnant women andprisoners will be excluded from this study

Study Design

Total Participants: 168
Treatment Group(s): 3
Primary Treatment: Radiation Therapy
Phase: 2
Study Start date:
August 26, 2021
Estimated Completion Date:
February 24, 2025

Study Description

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.

Connect with a study center

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Cooper Hospital UNIV MED CTR.

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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