Melanoma Margins Excision Trial (MelMarT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Norfolk and Norwich University Hospitals NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Australia & New Zealand Melanoma Trials Group
Information provided by (Responsible Party):
Marc Moncrieff, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01457157
First received: October 19, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

Recent data analysis has shown that data are seriously lacking on the safety and efficacy of margins less than 2cm for melanomas >2mm in Breslow thickness, and arguably insufficient for melanomas >1mm in thickness, for loco-regional control of melanoma recurrence. No RCT currently addresses 1 vs 2cm margins for melanomas in the >1mm thickness group. A trial is needed to answer this question.

Patients entering into the trial will be randomised to have either a 1cm margin around their melanoma or a 2cm margin. The study will look ot see whether a 1cm margin is safe in terms of melanoma recurrence or progression and has a better outcome for patients in terms of quality of life and side effects from the surgery.


Condition Intervention Phase
Melanoma
Procedure: Surgical Excision Margin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Melanoma Margins Excision Trial: A Randomised Controlled Trial Comparing 1cm Versus 2cm Excision Margins for Primary Cutaneous Melanoma

Resource links provided by NLM:


Further study details as provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Local Recurrence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Recurrence of melanoma in the scar or in the regional skin (in transits or satellites)

  • Melanoma Specific Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Death from melanoma druing the study period


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Qulaity of Life after surgery

  • Health Economical Analysis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    A measure of health care expenses between the two groups and clinical effectiveness

  • Surgical Complication Rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    The incidence of morbidity and moratlity associated with the surgery


Estimated Enrollment: 10500
Study Start Date: November 2012
Arms Assigned Interventions
Active Comparator: 2cm Margin
2cm surgical margin around melanoma scar
Procedure: Surgical Excision Margin
Surgical excision around cutaneous melanoma primary
Experimental: 1cm Margin
1cm surgical margin around melanoma scar
Procedure: Surgical Excision Margin
Surgical excision around cutaneous melanoma primary

Detailed Description:

Aim To conduct a RCT to establish whether there is a difference between local recurrence (wound scar, in-transit or satellite recurrence) for patients treated with a 1cm vs 2cm radial excision margin for >1mm thick primary invasive melanomas.

To determine, with the evidence provided by a RCT, the safety and efficacy of treatment of >1mm Breslow thickness primary invasive melanoma using a 1cm vs 2cm radial excision margin. Measurable endpoints are local recurrence; melanoma-specific and disease-free survival. Secondary endpoints will include patient satisfaction with their surgical treatment and scars as part of a quality of life assessment using structured questionnaires, in addition to an analysis on length of hospital stay and surgical complication rate which will provide an indirect assessment of financial and health care burden the two treatment arms entail.

Study design The study design follows a large simple trial format of a phase III randomised clinical non-inferiority study comparing 1cm excision margins (ARM A) versus 2cm excision margin (ARM B) for cutaneous melanomas >1mm in Breslow thickness. The non-inferiority study will provide the opportunity to rule out small but clinically important lower local recurrence rate in the 1cm margin arm. Local recurrence rate is the primary endpoint. For the purpose of this study, local recurrence rate will be include recurrence adjacent to the scar, satellite lesions and in transit metastases distal to the primary draining nodal field.

The accrual goal is 10,000 patients over 7 years with an equal number of patients in each arm The final assessment of overall local recurrence rate will be at ten years following completion of patient accrual. Some secondary endpoint analyses will also be performed at 1 and 5 years post-treatment Outcome measurements

Primary endpoint:

- Local recurrence rate

Secondary endpoints:

  • Regional recurrence rate
  • Melanoma-specific survival
  • Surgical Complications
  • Duration of hospital stay
  • Quality of Life analysis
  • Health Economics Analysis - Clinical Effectiveness Population Patients with a >1 mm Breslow thickness primary cutaneous melanoma, in a body area where a 2cm radial margin of resection is technically feasible, who are able to consent to the study Data Analysis A survival analysis will be used to analyse the primary endpoint (local recurrence) using Cox's Proportional Hazards model. Non-inferiority will be based upon the hazard ratio; if the upper 95% confidence limit does not exceed a ratio of 1.5 (1cm group to 2cm group) non-inferiority will be accepted. The study sample size is based upon a recurrence rate of 2% in ARM B (i.e. 2cm margin group). Thus, non-inferiority will imply a recurrence of less than 3% in ARM A (1cm margin) group. Each arm will require 4605 patients to provide a 90% statistical power to detect a difference of this magnitude. Allowing for loss to follow-up of 10%, 10,000 patients will be required.

Null Hypothesis As a non-inferiority study, the null hypothesis is that there is an increase in local recurrence rate in ARM A (1cm margin group) compared to ARM B of at least 1%.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.

    • Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
    • Randomisation must take place within 90 days of original diagnosis
    • Patients must be 18 years or over at time of consent.
    • Patient must be able to give informed consent.
    • Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
    • 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
    • The patient agrees to be followed up at an investigating centre for 10 years.

Exclusion Criteria:

  • • Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.

    • Patient has already undergone wide local excision at the site of the primary index lesion.
    • 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.
    • History of previous or concurrent (i.e., second primary) invasive melanoma.
    • Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear.
    • Primary melanoma of the eye, ears, mucous membranes or internal viscera.
    • Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic disease.
    • 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.
    • Any additional solid tumor or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine cervical cancer.
    • Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage
    • Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, or be exacerbated by therapy (e.g., severe depression).
    • Melanoma-related operative procedures not corresponding to criteria described in the protocol.
    • Primary or secondary immune deficiencies or known significant autoimmune disease.
    • History of organ transplantation.
    • Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457157

Contacts
Contact: Marc D Moncrieff, MD FRCS(Plast.) +441603288127 marc.moncrieff@nnuh.nhs.uk

Locations
United Kingdom
Norfolk & Norwich University Hospital Not yet recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Marc D Moncrieff, MD FRCS(Plast.)    +441603288127    marc.moncrieff@nnuh.nhs.uk   
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
Australia & New Zealand Melanoma Trials Group
Investigators
Principal Investigator: Marc D Moncrieff, MD FRCS(plast.) Norfolk & Norwich University Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Marc Moncrieff, Consultant Plastic & Reconstructive Surgeon, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01457157     History of Changes
Other Study ID Numbers: 2011PLAS03
Study First Received: October 19, 2011
Last Updated: October 19, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:
Melanoma
Cutaneous Melanoma
Skin Cancer
Surgery

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

ClinicalTrials.gov processed this record on August 18, 2014