Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma (MelPORT)

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Melanoma

Treatments: Other: Immunotherapy; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04594187

NCI-2020-06904 (Registry Identifier)

2020-0148 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)
• 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Group I (immunotherapy, radiation therapy)

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Other: Quality-of-Life Assessment

Other: Immunotherapy

Group II (immunotherapy)

Active Comparator group

Description:

Patients planned to undergo immunotherapy.

Treatment:

Other: Quality-of-Life Assessment

Other: Immunotherapy