Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04594187
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immunotherapy — OTHER
    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.
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Radiation Therapy — RADIATION
    Undergo nodal radiation therapy

Study Details

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.

Key Dates

Start date
Aug 26, 2021
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Group II (immunotherapy)
    Patients planned to undergo immunotherapy.

Primary Outcome Measure

Time to regional nodal recurrence [ Time Frame: From date of sentinel lymph node biopsy, assessed up to 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Baptist - MD Anderson Cancer CenterJacksonvilleFlorida32207
Cynthia Anderson, MD
[email protected]
904-202-7300
Cooper Hospital UNIV MED CTR.CamdenNew Jersey08103
Gregory Kubicek, MD
[email protected]
855-632-2667
Gregory Kubicek, MD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Devarati Mitra
[email protected]
713-563-1339
Devarati Mitra (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Baptist - MD Anderson Cancer Center· Jacksonville, FLCooper Hospital UNIV MED CTR.· Camden, NJM D Anderson Cancer Center· Houston, TX

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