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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 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.
Study details:
This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness \> 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease.
This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2019-12-17
Primary completion: 2029-12-31
Study completion finish: 2034-12-31
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT03860883
Intervention or treatment
PROCEDURE: Wide Local Excision = 1cm Margin
PROCEDURE: Wide Local Excision = 2cm Margin
Conditions
- • Cutaneous Melanoma, Stage II
Find a site
Closest Location:
The Canberra Hospital
Research sites nearby
Select from list below to view details:
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm A (Wide Local Excision = 1cm Margin)
| PROCEDURE: Wide Local Excision = 1cm Margin
|
ACTIVE_COMPARATOR: Arm B (Wide Local Excision = 2cm Margin)
| PROCEDURE: Wide Local Excision = 2cm Margin
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Disease-Free Survival | Time from randomisation to clinically, histologically or radiologically confirmed recurrence of melanoma | 0-60 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Local Recurrence | Time from randomisation to any clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes | Day 0-Trial Completion (max. 120 months) |
Distant Disease-Free Survival | Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma | Day 0-Trial Completion (max. 120 months) |
Melanoma-Specific Survival | Time from randomisation to death due to melanoma | Day 0-Trial Completion (max. 120 months) |
Overall Survival | Time from randomisation to death from any cause | Day 0-Trial Completion (max. 120 months) |
Melanoma-specific Quality of Life: FACT-M questionnaire | Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire - It consists of two subsections: The FACT-G subsection is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is considered appropriate for use with patients with any form of cancer. The Melanoma Surgery Subscale evaluates melanoma-specific symptoms such as surgical morbidity and side effects. | Baseline, 3, 6, 12 & 24 months |
Neuropathic Pain: PainDetect questionnaire | Measured by PainDetect questionnaire | Baseline, 3, 6, 12 & 24 months |
Health-related Quality of Life: EQ-5D-5L questionnaire | Measured by EuroQoL EQ-5D-5L questionnaire - This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | Baseline, 3, 6, 12 & 24 months |
Surgery Related Adverse Events | The following surgical adverse events will be recorded from the time of surgery to 90 days following surgery (inclusive): * wound dehiscence * seroma/haematoma * haemorrhage * infection * skin graft failure * necrosis of flap used for reconstruction * deep venous thrombosis * urinary tract infection * pneumonia * cardiac complications * lymphoedema | Up to 90 days from the date of surgery |
Adverse Events | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness. | Within 1 year from randomisation |
Health Economic Evaluation | Data collected for economic analysis will be from hospital notes, MBS and PBS data (Australia) and patient reported outcome measures (including an employment questionnaire) at baseline, 3, 6, 12 and 24 months and at melanoma recurrence. | Baseline, 3, 6, 12 & 24 months |
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