RECRUITING

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-26
Study Completion:2025-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04594187

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be planned for post-operative immunotherapy
  2. * No evidence of distant metastasis as determined by clinical examination and any form of imaging
  3. * No evidence of clinically involved lymph nodes prior to SLNB
  4. * 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)
  5. * Has provided written informed consent for participation in this trial
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
  7. * Life expectancy greater than 6 months
  8. * Patients capable of childbearing are using adequate contraception
  9. * Available for follow-up
  1. * Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
  2. * Distant metastasis
  3. * 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
  4. * Women who are pregnant
  5. * Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study

Contacts and Locations

Study Contact

Devarati Mitra
CONTACT
713-563-1339
dmitra@mdanderson.org

Principal Investigator

Devarati Mitra
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

Baptist - MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
Cooper Hospital UNIV MED CTR.
Camden, New Jersey, 08103
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Devarati Mitra, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2021-08-26
Study Completion Date2025-02-24

Study Record Updates

Study Start Date2021-08-26
Study Completion Date2025-02-24

Terms related to this study

Additional Relevant MeSH Terms

  • Melanoma