RecruitingPhase 2NCT04594187

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

168 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding targeted radiation to the lymph nodes can reduce the chance of melanoma returning after a positive sentinel lymph node biopsy (a procedure that checks whether cancer has spread to nearby lymph nodes). Participants will also receive immunotherapy after surgery. **You may be eligible if...** - You have melanoma that tested positive in a sentinel lymph node biopsy - Your lymph node involvement has high-risk features (such as cancer extending outside the lymph node capsule, multiple involved nodes, or cancer invading nearby blood vessels) - You are planned to receive immunotherapy after surgery - There is no evidence of cancer having spread to distant parts of the body - You are in reasonably good overall health **You may NOT be eligible if...** - You have already had a full lymph node dissection (removal of all nearby lymph nodes) - Cancer has spread to distant organs - The area to be treated has already received radiation in the past - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERImmunotherapy

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.

OTHERQuality-of-Life Assessment

Ancillary studies

RADIATIONRadiation Therapy

Undergo nodal radiation therapy


Locations(3)

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, United States

Cooper Hospital UNIV MED CTR.

Camden, New Jersey, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04594187


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