Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma (MelPORT)

February 12, 2026 updated by: M.D. Anderson Cancer Center

The Role of Nodal Radiation Therapy in 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist - MD Anderson Cancer Center
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Hospital UNIV MED CTR.
        • Contact:
        • Principal Investigator:
          • Gregory Kubicek, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Devarati Mitra

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: 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.
Other Names:
  • Immunological
  • Immunological Therapy
  • Immunologically Directed Therapy
Radiation: Radiation Therapy
Undergo nodal radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Active Comparator: Group II (immunotherapy)
Patients planned to undergo immunotherapy.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: 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.
Other Names:
  • Immunological
  • Immunological Therapy
  • Immunologically Directed Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of sentinel lymph node biopsy, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of sentinel lymph node biopsy, assessed up to 5 years
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.
From date of sentinel lymph node biopsy, assessed up to 5 years
Progression-free survival
Time Frame: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Overall survival
Time Frame: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
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.
Up to 5 years
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.
At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy

Other Outcome Measures

Outcome Measure
Time Frame
Tissue associated biomarkers of disease control and radiation-associated toxicity
Time Frame: Up to 5 years
Up to 5 years
Optional blood associated biomarkers of disease control and radiation-associated toxicity
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Devarati Mitra, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 10, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0148 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-06904 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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