Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594187
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Melanoma Other: Immunotherapy Other: Quality-of-Life Assessment Radiation: Radiation Therapy Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
Actual Study Start Date : August 26, 2021
Estimated Primary Completion Date : February 24, 2025
Estimated Study Completion Date : February 24, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
Other Names:
  • Immunological
  • Immunological Therapy
  • Immunologically Directed Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
Undergo nodal radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Active Comparator: Group II (immunotherapy)
Patients planned to undergo immunotherapy.
 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.
Other Names:
  • Immunological
  • Immunological Therapy
  • Immunologically Directed Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to regional nodal recurrence [ Time Frame: 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 :
  1. Time to locoregional recurrence [ Time Frame: 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.

  2. Time to distant metastasis [ Time Frame: 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.

  3. Progression-free survival [ Time Frame: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years ]
  4. Overall survival [ Time Frame: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years ]
  5. Incidence of long term toxicity [ Time Frame: 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.

  6. Patient reported quality of life [ 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 ]
    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.


Other Outcome Measures:
  1. Tissue associated biomarkers of disease control and radiation-associated toxicity [ Time Frame: Up to 5 years ]
  2. Optional blood associated biomarkers of disease control and radiation-associated toxicity [ Time Frame: Up to 5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594187


Contacts
Layout table for location contacts
Contact: Devarati Mitra 713-563-1339 dmitra@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Devarati Mitra    713-563-1339    dmitra@mdanderson.org   
Principal Investigator: Devarati Mitra         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Devarati Mitra M.D. Anderson Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04594187    
Other Study ID Numbers: 2020-0148
NCI-2020-06904 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0148 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas