Wide Local Excision = 1cm Margin for Cutaneous Melanoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Hospitals Avon Health Center, Avon, OHCutaneous MelanomaWide Local Excision = 1cm Margin - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a less radical surgery is just as effective as a more radical surgery for melanoma.

Eligible Conditions
  • Cutaneous Melanoma Stage II

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Within 1 year from randomisation

0-60 months
Disease-Free Survival
Month 24
Health Economic Evaluation
Health-related Quality of Life: EQ-5D-5L questionnaire
Melanoma-specific Quality of Life: FACT-M questionnaire
Neuropathic Pain: PainDetect questionnaire
Month 120
Distant Disease-Free Survival
Local Recurrence
Melanoma-Specific Survival
Overall Survival
Day 90
Surgery Related Adverse Events
Year 1
Adverse Events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm B (Wide Local Excision = 2cm Margin)
1 of 2
Arm A (Wide Local Excision = 1cm Margin)
1 of 2

Active Control

Experimental Treatment

2998 Total Participants · 2 Treatment Groups

Primary Treatment: Wide Local Excision = 1cm Margin · No Placebo Group · Phase 3

Arm A (Wide Local Excision = 1cm Margin)
Procedure
Experimental Group · 1 Intervention: Wide Local Excision = 1cm Margin · Intervention Types: Procedure
Arm B (Wide Local Excision = 2cm Margin)
Procedure
ActiveComparator Group · 1 Intervention: Wide Local Excision = 2cm Margin · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 1 year from randomisation

Who is running the clinical trial?

Norfolk and Norwich University Hospitals NHS Foundation TrustOTHER
44 Previous Clinical Trials
24,617 Total Patients Enrolled
Cancer Trials IrelandNETWORK
79 Previous Clinical Trials
20,727 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
116 Previous Clinical Trials
62,844 Total Patients Enrolled
Zuyderland Medical CentreOTHER
18 Previous Clinical Trials
65,211 Total Patients Enrolled
Melanoma and Skin Cancer Trials LimitedLead Sponsor
14 Previous Clinical Trials
3,392 Total Patients Enrolled
Marc MoncrieffStudy ChairNorfolk & Norwich University Hospital
1 Previous Clinical Trials
400 Total Patients Enrolled
Michael HendersonStudy ChairPeter MacCallum Cancer Centre, Australia
2 Previous Clinical Trials
415 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
It is possible to remove the cancerous tissue along with a 2cm margin around it without causing any technical difficulties.

Frequently Asked Questions

How large is the test group for this experiment?

"The information available on clinicaltrials.gov does show that this trial is actively recruiting patients as of right now. This trial was initially posted on December 17th, 2019 and the most recent update was October 24th, 2020. They are looking for 2,998 patients in total from 48 different sites." - Anonymous Online Contributor

Unverified Answer

Is the FDA's decision to approve Wide Local Excision with a 1cm Margin supported by scientific research?

"Power has given Wide Local Excision = 1cm Margin a safety score of 3. This is based off the fact that it is a phase 3 trial, and thus there is both evidence of efficacy as well as multiple rounds of data supporting safety." - Anonymous Online Contributor

Unverified Answer

In how many different locations is this trial being conducted?

"In total, there are 48 patients enrolled in this trial at various locations including VCU Massey Cancer Center in Richmond, Marshfield Medical Center - Marshfield in Marshfield, and University of Kansas Hospital - Indian Creek Campus in Overland Park." - Anonymous Online Contributor

Unverified Answer

Is this research available to participants at the present time?

"Yes, the trial is recruiting patients as of now. The date when this study was first posted on clinicaltrials.gov was December 17th, 2019 and the most recent update to the trial information occurred on October 24th, 2020." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.