Clinical Trials /

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

NCT04594187

Description:

This phase III 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. Patients with a positive inguinal node will be excluded due to increased risk of radiation-associated toxicity at this site. 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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
  • Official Title: The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma

Clinical Trial IDs

  • ORG STUDY ID: 2020-0148
  • SECONDARY ID: NCI-2020-06904
  • SECONDARY ID: 2020-0148
  • NCT ID: NCT04594187

Conditions

  • Melanoma

Purpose

This phase III 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. Patients with a positive inguinal node will be excluded due to increased risk of radiation-associated toxicity at this site. 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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Group I (immunotherapy, radiation therapy)ExperimentalWithin 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.
    Group II (immunotherapy)Active ComparatorPatients planned to undergo immunotherapy.

      Eligibility Criteria

              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 1 mm+ nodal tumor implant)
      
                -  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:
      
                -  Inguinal sentinel lymph node (SLN) involvement
      
                -  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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Time to regional nodal recurrence
      Time Frame:From date of sentinel lymph node biopsy, assessed up to 5 years
      Safety Issue:
      Description:Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up

      Secondary Outcome Measures

      Measure:Time to locoregional recurrence
      Time Frame:From date of sentinel lymph node biopsy, assessed up to 5 years
      Safety Issue:
      Description: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.
      Measure:Time to distant metastasis
      Time Frame:From date of sentinel lymph node biopsy, assessed up to 5 years
      Safety Issue:
      Description:Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.
      Measure:Progression-free survival
      Time Frame:From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
      Safety Issue:
      Description:
      Measure:Overall survival
      Time Frame:From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
      Safety Issue:
      Description:
      Measure:Incidence of long term toxicity
      Time Frame:Up to 5 years
      Safety Issue:
      Description: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.
      Measure: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
      Safety Issue:
      Description: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.

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:M.D. Anderson Cancer Center

      Last Updated

      October 13, 2020