Melanoma Clinical Trial

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Summary

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.

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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.

View Eligibility Criteria

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 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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT04594187

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There are 2 Locations for this study

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Cooper Hospital UNIV MED CTR.
Camden New Jersey, 08103, United States More Info
Gregory Kubicek, MD
Contact
855-632-2667
[email protected]
Gregory Kubicek, MD
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Devarati Mitra
Contact
713-563-1339
[email protected]
Devarati Mitra
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT04594187

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

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