Health TrialsbyHealthPanel

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunotherapy

    Other intervention

    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 intervention

    Ancillary studies

  • Radiation Therapy

    Radiation

    Undergo nodal radiation therapy

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Group I (immunotherapy, radiation therapy)Experimental treatment 3 interventions
Group B: Group II (immunotherapy)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to regional nodal recurrence

Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up

Time frame
From date of sentinel lymph node biopsy, assessed up to 5 years

Secondary outcomes

1

Time to locoregional recurrence

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.

Time frame
From date of sentinel lymph node biopsy, assessed up to 5 years
2

Time to distant metastasis

Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.

Time frame
From date of sentinel lymph node biopsy, assessed up to 5 years
3

Progression-free survival

Time frame
From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
4

Overall survival

Time frame
From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years

Other outcomes

1

Tissue associated biomarkers of disease control and radiation-associated toxicity

Time frame
Up to 5 years
2

Optional blood associated biomarkers of disease control and radiation-associated toxicity

Time frame
Up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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