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Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma (MelPORT)

Primary Purpose

Melanoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Immunotherapy
Quality-of-Life Assessment
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist - MD Anderson Cancer CenterRecruiting
  • Cooper Hospital UNIV MED CTR.Recruiting
  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (immunotherapy, radiation therapy)

Group II (immunotherapy)

Arm Description

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.

Patients planned to undergo immunotherapy.

Outcomes

Primary Outcome Measures

Time to regional nodal recurrence
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up

Secondary Outcome Measures

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.
Time to distant metastasis
Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.
Progression-free survival
Overall survival
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.
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.

Full Information

First Posted
October 10, 2020
Last Updated
April 4, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04594187
Brief Title
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
Acronym
MelPORT
Official Title
The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
February 24, 2025 (Anticipated)
Study Completion Date
February 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (immunotherapy, radiation therapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (immunotherapy)
Arm Type
Active Comparator
Arm Description
Patients planned to undergo immunotherapy.
Intervention Type
Other
Intervention Name(s)
Immunotherapy
Other Intervention Name(s)
Immunological, Immunological Therapy, Immunologically Directed Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo nodal radiation therapy
Primary Outcome Measure Information:
Title
Time to regional nodal recurrence
Description
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up
Time Frame
From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Time to locoregional recurrence
Description
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.
Time Frame
From date of sentinel lymph node biopsy, assessed up to 5 years
Title
Time to distant metastasis
Description
Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.
Time Frame
From date of sentinel lymph node biopsy, assessed up to 5 years
Title
Progression-free survival
Time Frame
From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Title
Overall survival
Time Frame
From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
Title
Incidence of long term toxicity
Description
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.
Time Frame
Up to 5 years
Title
Patient reported quality of life
Description
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 Frame
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 Pre-specified Outcome Measures:
Title
Tissue associated biomarkers of disease control and radiation-associated toxicity
Time Frame
Up to 5 years
Title
Optional blood associated biomarkers of disease control and radiation-associated toxicity
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devarati Mitra
Phone
713-563-1339
Email
dmitra@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devarati Mitra
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist - MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Anderson, MD
Phone
904-202-7300
Email
cynthia.anderson@bmcjax.com
Facility Name
Cooper Hospital UNIV MED CTR.
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Kubicek, MD
Phone
855-632-2667
Email
Kubicek-Gregory@CooperHealth.edu
First Name & Middle Initial & Last Name & Degree
Gregory Kubicek, MD
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devarati Mitra
Phone
713-563-1339
Email
dmitra@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Devarati Mitra

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

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