What this study is
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.
What's being tested
- Immunotherapy
Intervention · 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
Intervention · OTHER
Ancillary studies
- Radiation Therapy
Intervention · RADIATION
Undergo nodal radiation therapy
Study details
- Official title
- The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Melanoma
- Enrolling
- 168 people
- Starts
- 2020-08-07
- Est. completion
- 2027-12-31
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openBaptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
- Cynthia Anderson, MD · Contact904-202-7300cynthia.anderson@bmcjax.com
RecruitingCooper Hospital UNIV MED CTR.
Camden, New Jersey, United States
- Gregory Kubicek, MD · Contact855-632-2667Kubicek-Gregory@CooperHealth.edu
- Gregory Kubicek, MD · Principal investigator
RecruitingM D Anderson Cancer Center
Houston, Texas, United States
- Devarati Mitra · Contact713-563-1339dmitra@mdanderson.org
- Devarati Mitra · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2020-0148
Principal investigator
Devarati Mitra
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.