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NCT03860883 · ClinicalTrials.gov registry record · NA

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

A NA study of Cutaneous Melanoma, Stage II, sponsored by Melanoma and Skin Cancer Trials Limited.

Recruiting
Registry status
NA
Development phase
2,998
Enrollment target
20
Study locations

NCT03860883: Recruiting NA study of Cutaneous Melanoma, Stage II, sponsored by Melanoma and Skin Cancer Trials Limited.

NCT03860883 is a NA study of Cutaneous Melanoma, Stage II that is actively recruiting participants, run by Melanoma and Skin Cancer Trials Limited. The registered enrollment target is 2,998 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03860883, a NA study of Cutaneous Melanoma, Stage II, is actively recruiting participants, sponsored by Melanoma and Skin Cancer Trials Limited.

RECRUITING
Registry status
NA
Development phase
2,998 participants
Enrollment target
20
Study locations

Study Summary

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Primary Outcome

Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.

Interventions

  • PROCEDURE Wide Local Excision = 1cm Margin
  • PROCEDURE Wide Local Excision = 2cm Margin

Study Locations (20)

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • Los Angeles General Medical Center - Los Angeles
  • Los Angeles General Medical Center - Los Angeles
  • USC Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Comprehensive Cancer Center - Los Angeles
  • The Angeles (Cedars-Sinai Medical Center and its Affiliates) - Los Angeles
  • UC Irvine Health - Chao Family Comprehensive Cancer Center - Orange
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Orange
  • Stanford Cancer Institute - Palo Alto
  • Huntington Memorial Hospital - Pasadena
  • Stanford Cancer Center South Bay - San Jose
  • Kaiser Permanente - Vallejo Medical Center - Vallejo
  • Kaiser Permanente - Walnut Creek Medical Center - Walnut Creek

Arizona

  • Banner MD Anderson Cancer Center - Gilbert
  • Mayo Clinic Phoenix - Phoenix

Connecticut

  • Smilow Hospital Care Center, Guilford - Guilford
  • Yale University - New Haven

Alabama

  • University of South Alabama Mitchell Cancer Institute - Mobile

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 2,998 participants
Start Date 2019-12-17
Est. Completion 2034-12-31
Phase NA

What NCT03860883 shows while recruiting

NCT03860883 is an interventional study that assigns participants to a tested intervention. Its 2,998 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher).

The record links to 1 condition, with Cutaneous Melanoma, Stage II appearing as the primary indexed condition, and to 2 interventions - of which Wide Local Excision = 1cm Margin is the first listed.

NCT03860883 names 20 study sites across 6 states, led by California, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT03860883 about?

NCT03860883 is a clinical study titled "Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma". Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for ...

What is the current status of trial NCT03860883?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,998 participants. The study started on 2019-12-17. Estimated completion is 2034-12-31.

What conditions does trial NCT03860883 study?

This clinical trial studies the following conditions: Cutaneous Melanoma, Stage II.

What interventions are being tested in trial NCT03860883?

The interventions under investigation include: Wide Local Excision = 1cm Margin (PROCEDURE), Wide Local Excision = 2cm Margin (PROCEDURE).

Who is sponsoring clinical trial NCT03860883?

This trial is sponsored by Melanoma and Skin Cancer Trials Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03860883 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03860883's enrollment target sits among peer trials

2,998 42nd of 2000 higher than 1,959 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03860883, the US trial registry maintained by the National Library of Medicine. NCT03860883 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.