NCT04594187 Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
| NCT ID | NCT04594187 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2021-08-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 168 participants in total. It began in 2021-08-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Devarati Mitra
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04594187 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04594187 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04594187 currently recruiting?
Yes, NCT04594187 is actively recruiting participants. Contact the research team at dmitra@mdanderson.org for enrollment information.
Where is the NCT04594187 trial being conducted?
This trial is being conducted at Jacksonville, United States, Camden, United States, Houston, United States.
Who is sponsoring the NCT04594187 clinical trial?
NCT04594187 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Devarati Mitra at M.D. Anderson Cancer Center. The trial plans to enroll 168 participants.
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