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NCT Number: NCT04594187

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

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 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

Treatment and study plan

Immunotherapy

Other

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.

Other names: Immunological, Immunological Therapy, Immunologically Directed Therapy

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

radiation therapy

Radiation

Undergo nodal radiation therapy

Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Primary outcomes

  1. Time to regional nodal recurrence

    Time frame: 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

Secondary outcomes

  1. Time to locoregional recurrence

    Time frame: From date of sentinel lymph node biopsy, assessed up to 5 years

    Local recurrence, locoregional recurrence (including both regional recurrence and local recurrence at the primary tumor site) will also be assessed by physical exam and routine surveillance imaging during follow-up.

  2. Time to distant metastasis

    Time frame: From date of sentinel lymph node biopsy, assessed up to 5 years

    Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.

  3. Progression-free survival

    Time frame: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years

  4. Overall survival

    Time frame: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years

  5. Incidence of long term toxicity

    Time frame: Up to 5 years

    Long term toxicity including lymphedema, infection, decreased mobility will be assessed at the time of routine follow up appointments. Physician-reported toxicity related to regional nodal disease or treatment will be recorded as per Common Terminology Criteria for Adverse Events version 5.0. Specific toxicity to be evaluated will include: fatigue, localized edema, lymphedema, pain, skin infection, soft tissue infection, thrush, radiation recall reaction, arthritis, fibrosis, joint range of motion, dysphagia, dysgeusia and dry skin.

  6. Patient reported quality of life

    Time frame: At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy

    Quality of life in all patients will be assessed by Functional Assessment of Cancer Therapy General survey. Patients with head and neck nodal disease will also be assessed by the University of Washington Quality of Life survey and patients with axillary nodal disease will also be assessed by the Lymphoedema Quality of Life-ARM.

Other outcomes

  1. Tissue associated biomarkers of disease control and radiation-associated toxicity

    Time frame: Up to 5 years

  2. Optional blood associated biomarkers of disease control and radiation-associated toxicity

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Devarati Mitra

CONTACT

[email protected]

713-563-1339

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Acronym: MelPORT

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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