Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Phase 2

Recruiting

• Conditions: Melanoma
• Interventions: Other: Immunotherapy; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy

• Registration Number: NCT04594187
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Study Start: 2021-08-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-02-24
• Study Completion: 2025-02-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (immunotherapy)	Quality-of-Life Assessment	Patients planned to undergo immunotherapy.
Group I (immunotherapy, radiation therapy)	Quality-of-Life Assessment	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.
Group I (immunotherapy, radiation therapy)	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.
Group II (immunotherapy)	Immunotherapy	Patients planned to undergo immunotherapy.
Group I (immunotherapy, radiation therapy)	Immunotherapy	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.

Primary Outcome Measures

Name	Time	Method
Time to regional nodal recurrence	From date of sentinel lymph node biopsy, assessed up to 5 years	Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up

Secondary Outcome Measures

Name	Time	Method
Time to locoregional recurrence	From date of sentinel lymph node biopsy, assessed up to 5 years	Local recurrence, locoregional recurrence (including both regional recurrence and local recurrence at the primary tumor site) will also be assessed by physical exam and routine surveillance imaging during follow-up.
Overall survival	From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
Progression-free survival	From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Incidence of long term toxicity	Up to 5 years	Long term toxicity including lymphedema, infection, decreased mobility will be assessed at the time of routine follow up appointments. Physician-reported toxicity related to regional nodal disease or treatment will be recorded as per Common Terminology Criteria for Adverse Events version 5.0. Specific toxicity to be evaluated will include: fatigue, localized edema, lymphedema, pain, skin infection, soft tissue infection, thrush, radiation recall reaction, arthritis, fibrosis, joint range of motion, dysphagia, dysgeusia and dry skin.
Patient reported quality of life	At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy	Quality of life in all patients will be assessed by Functional Assessment of Cancer Therapy General survey. Patients with head and neck nodal disease will also be assessed by the University of Washington Quality of Life survey and patients with axillary nodal disease will also be assessed by the Lymphoedema Quality of Life-ARM.
Time to distant metastasis	From date of sentinel lymph node biopsy, assessed up to 5 years	Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.

Trial Locations

Locations (3)

Baptist - MD Anderson Cancer Center; 🇺🇸 Jacksonville, Florida, United States

Cooper Hospital UNIV MED CTR.; 🇺🇸 Camden, New Jersey, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States