NCT03034395

Brief Summary

This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 30, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

January 23, 2017

Last Update Submit

April 29, 2021

Conditions

Malignant Melanoma

Keywords

MelanomacT2N0M0

Outcome Measures

Primary Outcomes (1)

  • Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.

    Number of patients who agree to participate

    2 years

Secondary Outcomes (2)

  • Recurrence (disease free survival)

    Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years

  • Quality of life following surgery

    One month post-surgery

Study Arms (2)

Wide Local Excision 1cm

OTHER
Procedure: Wide Local Excision

Wide Local Excision 2cm

OTHER
Procedure: Wide Local Excision

Interventions

Wide Local ExcisionPROCEDURE

Surgery

Wide Local Excision 1cmWide Local Excision 2cm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven T2 malignant melanoma.
  • Eastern Cooperative Oncology Group (ECOG) score of 0-2.

You may not qualify if:

  • Visible additional disease that suggests a greater than T2 malignant melanoma
  • Unable to tolerate general anesthesia
  • Evidence of distant metastatic disease
  • Melanoma located on face or digits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Joshua Mammen, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 27, 2017

Study Start

January 30, 2017

Primary Completion

May 3, 2019

Study Completion

November 4, 2020

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

US(1)