Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

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Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04594187
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Devarati Mitra
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

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.

Interventions

Other: - Immunotherapy

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.

Other: - Quality-of-Life Assessment

Ancillary studies

Radiation: - Radiation Therapy

Undergo nodal radiation therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baptist - MD Anderson Cancer Center, Jacksonville, Florida

Status

Recruiting

Address

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, 32207

Site Contact

Cynthia Anderson, MD

[email protected]

904-202-7300

Cooper Hospital UNIV MED CTR., Camden, New Jersey

Status