Study on Nodal Radiation Therapy for Patients with Sentinel Lymph Node Positive Melanoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04594187

Provider View

This clinical trial is exploring whether adding nodal radiation therapy to immunotherapy can help prevent the return of melanoma in patients with high-risk sentinel lymph node positive melanoma, without needing further lymph node surgery.

Patient Parameters

Program Overview

The purpose of this study is to find out if using nodal radiation therapy after a sentinel lymph node biopsy can help reduce the chance of melanoma coming back in patients who are at high risk and are receiving immunotherapy. Previous research has shown that nodal radiation can lower the risk of cancer returning in more advanced cases, but it's unclear if it will have the same effect in these patients.

Description

The main goal of this study is to see if nodal radiation therapy can delay the return of melanoma in the regional lymph nodes.

Participants in the study will be randomly assigned to one of two groups:

  • Group I: Patients will receive both immunotherapy and nodal radiation therapy. The radiation therapy will be given in 5 treatments over 2 to 2.5 weeks.
  • Group II: Patients will receive only immunotherapy.

After finishing the study treatment, patients will have follow-up visits every 3 months for the first 2 years, and then every 6 months for the next 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must be scheduled to receive immunotherapy after surgery.
  • No signs of cancer spreading to distant parts of the body, as shown by exams and imaging tests.
  • No signs of cancer in lymph nodes before the sentinel lymph node biopsy.
  • Confirmed diagnosis of sentinel lymph node positive melanoma with high-risk features, such as cancer spreading outside the lymph node capsule, a tumor implant of 0.5 mm or larger, involvement of 2 or more nodes, or cancer spreading through blood vessels in the primary tumor.
  • Must have signed a consent form to participate in the study.
  • Have an ECOG performance status of 3 or less, indicating the ability to perform daily activities.
  • Expected to live more than 6 months.
  • Patients who can have children must use effective birth control.
  • Must be available for follow-up appointments.

Exclusion Criteria

  • Have had a complete lymph node removal in the area with the positive sentinel lymph node.
  • Have cancer that has spread to distant parts of the body.
  • Have had previous radiation therapy to the area planned for treatment in this study, which would require re-irradiation.
  • Are pregnant.
  • Are unable to give consent, are underage, or are prisoners.

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