Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

Melanoma Clinical Trial

— MelPORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594187
• Other study ID #: 2020-0148
• Secondary ID: NCI-2020-0690420
• Status: Recruiting
• Phase: Phase 2
• Start date: August 26, 2021
• Est. completion date: February 24, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Devarati Mitra
• Phone: 713-563-1339
• Email: dmitra[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: February 24, 2025
• Est. primary completion date: February 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Immunotherapy
All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
• Quality-of-Life Assessment
Ancillary studies

Radiation:
• Radiation Therapy
Undergo nodal radiation therapy

Locations

Country	Name	City	State
United States	Cooper Hospital UNIV MED CTR.	Camden	New Jersey
United States	M D Anderson Cancer Center	Houston	Texas
United States	Baptist - MD Anderson Cancer Center	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tissue associated biomarkers of disease control and radiation-associated toxicity		Up to 5 years
Other	Optional blood associated biomarkers of disease control and radiation-associated toxicity		Up to 5 years
Primary	Time to regional nodal recurrence	Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up	From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary	Time to locoregional recurrence	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.	From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary	Time to distant metastasis	Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.	From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary	Progression-free survival		From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Secondary	Overall survival		From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
Secondary	Incidence of long term toxicity	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.	Up to 5 years
Secondary	Patient reported quality of life	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.	At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy

External Links

•   MD Anderson Cancer Center