Nodal radiation therapy for melanoma with positive sentinel lymph nodes
The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
This study is testing if adding radiation therapy to immunotherapy can help people with high-risk melanoma that has spread to their lymph nodes stay cancer-free longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 3 sites (Jacksonville, Florida and 2 other locations) |
| Trial ID | NCT04594187 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of nodal radiation therapy combined with immunotherapy for patients with high-risk sentinel lymph node positive melanoma. Participants will be randomized into two groups: one receiving both radiation therapy and immunotherapy, and the other receiving only immunotherapy. The primary goal is to assess whether the addition of radiation therapy prolongs the time to regional recurrence of melanoma. Patients will be monitored for up to five years after treatment to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically confirmed sentinel lymph node positive melanoma who are planned for post-operative immunotherapy.
Not a fit: Patients who have undergone complete lymph node dissection or have distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of melanoma recurrence in patients with high-risk sentinel lymph node positive disease.
How similar studies have performed: Previous studies have shown that nodal radiation therapy can decrease the risk of recurrence in more advanced melanoma, suggesting potential success for this approach in high-risk patients.
Eligibility criteria
Show full 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
Where this trial is running
Jacksonville, Florida and 2 other locations
- Baptist - MD Anderson Cancer Center — Jacksonville, Florida, United States (Recruiting)
- Cooper Hospital UNIV MED CTR. — Camden, New Jersey, United States (Recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Devarati Mitra — M.D. Anderson Cancer Center
- Study coordinator: Devarati Mitra
- Email: dmitra@mdanderson.org
- Phone: 713-563-1339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.