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

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ClinicalTrials.gov Identifier: NCT03860883
Recruitment Status : Not yet recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Australia and New Zealand Melanoma Trials Group

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 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.

Condition or disease Intervention/treatment Phase
Cutaneous Melanoma, Stage II Procedure: Wide Local Excision = 1cm Margin Procedure: Wide Local Excision = 2cm Margin Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2998 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (ANZMTG 02.18 MelMarT-II)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Arm A (Wide Local Excision = 1cm Margin)
1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Procedure: Wide Local Excision = 1cm Margin
A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.

Active Comparator: Arm B (Wide Local Excision = 2cm Margin)
2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Procedure: Wide Local Excision = 2cm Margin
A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.




Primary Outcome Measures :
  1. Disease-Free Survival [ Time Frame: 0-60 months ]
    Time from randomisation to clinically, histologically or radiologically confirmed recurrence of melanoma


Secondary Outcome Measures :
  1. Local Recurrence [ Time Frame: Day 0-Trial Completion (max. 120 months) ]
    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

  2. Distant Disease-Free Survival [ Time Frame: Day 0-Trial Completion (max. 120 months) ]
    Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma

  3. Melanoma-Specific Survival [ Time Frame: Day 0-Trial Completion (max. 120 months) ]
    Time from randomisation to death due to melanoma

  4. Overall Survival [ Time Frame: Day 0-Trial Completion (max. 120 months) ]
    Time from randomisation to death from any cause

  5. Melanoma-specific Quality of Life: FACT-M questionnaire [ Time Frame: Baseline, 3, 6, 12 & 24 months ]
    Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire

  6. Neuropathic Pain: PainDetect questionnaire [ Time Frame: Baseline, 3, 6, 12 & 24 months ]
    Measured by PainDetect questionnaire

  7. Health-related Quality of Life: EQ-5D-5L questionnaire [ Time Frame: Baseline, 3, 6, 12 & 24 months ]
    Measured by EuroQoL EQ-5D-5L questionnaire

  8. Surgery Related Adverse Events [ Time Frame: Up to 30 days from surgery ]

    The following surgical adverse events will be recorded from the time of surgery to 30 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

  9. Adverse Events [ Time Frame: Within 1 year from randomisation ]
    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.

  10. Health Economic Evaluation [ Time Frame: Baseline, 3, 6, 12 & 24 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have an invasive primary cutaneous melanoma with Breslow thickness > 2mm, or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
  2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, or sole).
  3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
  4. Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed within 120 days of the original diagnosis.
  5. Patients must be 18 years or older at time of consent.
  6. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
  7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
  8. Patients must have an ECOG performance score between 0 and 1.
  9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:

    • The patient has undergone potentially curative therapy for all prior malignancies,
    • There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
    • The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.

Exclusion Criteria:

  1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
  2. Patient has already undergone wide local excision at the site of the primary index lesion.
  3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
  4. Desmoplastic or neurotropic melanoma.
  5. Microsatellitosis as per AJCC 8th edition definition
  6. Subungual melanoma
  7. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
  8. History of previous or concurrent (i.e., second primary) invasive melanoma.
  9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
  10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
  11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
  12. Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.
  13. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
  14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.
  15. History of organ transplantation.
  16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860883


Contacts
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Contact: ANZMTG Project Officer 61 2 9911 7352 melmart@melanoma.org.au

Locations
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Australia, New South Wales
Melanoma Institute Australia Not yet recruiting
Sydney, New South Wales, Australia
Contact: Andrew Spillane         
Principal Investigator: Andrew Spillane         
Royal Prince Alfred Hospital Not yet recruiting
Sydney, New South Wales, Australia
Contact: Robyn Saw         
Principal Investigator: Robyn Saw         
Australia, Victoria
Peter MacCallum Cancer Centre Not yet recruiting
Melbourne, Victoria, Australia
Contact: Michael Henderson         
Principal Investigator: Michael Henderson         
Sub-Investigator: David Gyorki         
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia
Contact: Victoria Mar         
Principal Investigator: Victoria Mar         
United Kingdom
Norfolk & Norwich University Hospital Not yet recruiting
Norwich, United Kingdom
Contact: Marc Moncrieff         
Principal Investigator: Marc Moncrieff         
Sponsors and Collaborators
Australia and New Zealand Melanoma Trials Group
Norfolk and Norwich University Hospitals NHS Foundation Trust
Investigators
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Study Chair: Michael Henderson Peter MacCallum Cancer Centre, Australia
Study Chair: Marc Moncrieff Norfolk & Norwich University Hospital

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Responsible Party: Australia and New Zealand Melanoma Trials Group
ClinicalTrials.gov Identifier: NCT03860883     History of Changes
Other Study ID Numbers: ANZMTG 02.18
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Australia and New Zealand Melanoma Trials Group:
Malignant
Melanoma
Cancer
Surgery

Additional relevant MeSH terms:
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Melanoma
Nevi and Melanomas
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Site
Skin Diseases