Clinical trial NCT04594187: Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Official title: The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Time to regional nodal recurrence
timeFrame: From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary outcomes:
measure: Time to locoregional recurrence
timeFrame: From date of sentinel lymph node biopsy, assessed up to 5 years
measure: Time to distant metastasis
timeFrame: From date of sentinel lymph node biopsy, assessed up to 5 years
measure: Progression-free survival
timeFrame: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
measure: Overall survival
timeFrame: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
measure: Incidence of long term toxicity
timeFrame: Up to 5 years
measure: Patient reported quality of life
timeFrame: At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy
Other outcomes:
measure: Tissue associated biomarkers of disease control and radiation-associated toxicity
timeFrame: Up to 5 years
measure: Optional blood associated biomarkers of disease control and radiation-associated toxicity
timeFrame: Up to 5 years
Locations:
city: Jacksonville
country: United States
facility: Baptist - MD Anderson Cancer Center
state: Florida
city: Camden
country: United States
facility: Cooper Hospital UNIV MED CTR.
state: New Jersey
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Devarati Mitra
role: PRINCIPAL_INVESTIGATOR
References: