Clinical Trial: MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III, Multi-centre, Multi-national Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

Brief 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 a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients

Detailed Summary: This study will determine whether there is a difference in local recurrence rates and melanoma survival rates for patients treated with either a 1cm excision margin or 2cm margin for both intermediate & high risk melanomas. 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. This study is designed to show that the risk of long-term pain associated with surgery can be halved. If the study shows no risk of the 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.
Sponsor: Australia and New Zealand Melanoma Trials Group

Current Primary Outcome: Local Melanoma Recurrence (Melanoma Specific Survival) [ Time Frame: 0-120 months ]

Time from randomisation to clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence-Free Survival [ Time Frame: 0-120 months ]
    Time from randomisation to any clinical, histological or radiologically confirmed melanoma recurrence or death from any cause.
  • QoL and neuropathic pain assessments Neuropathic Pain (PainDetect) [ Time Frame: Baseline, 3, 6 12, 24 & 60 months. ]
    Quality of Life
  • Overall Survival [ Time Frame: 0-120 Months ]
    Time from randomisation to death from any cause.
  • Adverse events [ Time Frame: Within 1 year ]

    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.

    AEs and any pre-existing medical conditions will be recorded at the Baseline assessment and routinely at Follow Up, until the participant completes the study, withdraws or dies.

  • Surgery related adverse events [ Time Frame: Up to 30 days from randomisation ]

    The following surgical adverse events will be recorded from the time of trial treatment to 30 days following the wide excision (inclusive):

    • wound separation
    • seroma/haematoma at wide local excision site
    • haemorrhage
    • infection
    • skin graft failure
    • necrosis of flap used for reconstruction
    • deep venous thrombosis
    • urinary tract infection
    • pneumonia
    • cardiac complications
  • Health System Resource Use [ Time Frame: Baseline, 3, 6, 12, 24 and 60 months ]
    All hospitalisations and other interventions will be captured in order to measure resource use.


Original Secondary Outcome: Same as current

Information By: Australia and New Zealand Melanoma Trials Group

Dates:
Date Received: June 13, 2014
Date Started: December 2014
Date Completion: December 2029
Last Updated: July 14, 2016
Last Verified: July 2016