The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma

Who is this study for? Patients with Melanoma
What treatments are being studied? Immunotherapy+Quality-of-Life Assessment
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Baptist - MD Anderson Cancer Center
RECRUITING
Jacksonville
New Jersey
Cooper Hospital UNIV MED CTR.
RECRUITING
Camden
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Devarati Mitra
dmitra@mdanderson.org
713-563-1339
Time Frame
Start Date: 2021-08-26
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 168
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov