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

NCT ID: NCT02385214

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-03
• Study Completion Date: 2026-08-05

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 Description

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.

Conditions

Cutaneous Melanoma by AJCC V7 Stage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A Wide Local Excision = 1cm Margin

ARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy

+/- Reconstruction

Group Type: EXPERIMENTAL

Wide Local Excision = 1cm Margin

Intervention Type: PROCEDURE

A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

Arm B Wide Local Excision = 2cm Margin

ARM B:Control Arm Wide Local Excision = 2cm Margin + Sentinel Lymph Node Biopsy

+/- Reconstruction

Group Type: ACTIVE_COMPARATOR

Wide Local Excision = 2cm Margin

Intervention Type: PROCEDURE

A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

Interventions

Wide Local Excision = 1cm Margin

A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

Intervention Type: PROCEDURE

Wide Local Excision = 2cm Margin

A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.

3. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).

4. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.

5. Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.

6. Patients must be 18 years or older at time of consent.

7. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.

8. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.

9. Patients must have an ECOG performance score between 0 and 1.

10. 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 2009 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role: collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Melanoma and Skin Cancer Trials Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Moncrieff

Role: PRINCIPAL_INVESTIGATOR

Norfolk & Norwich University Hospital

Michael Henderson

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Center

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Melanoma Institute Australia - Poche Centre

North Sydney, New South Wales, Australia

Gold Coast Melanom Clinic

Coolangatta, Queensland, Australia

Peter MacCallum Cancer Centre Division of Cancer Surgery

Melbourne, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Sunnybrook Health Sciences Centre

Toronto, , Canada

Sahlgrenska University Hospital

Gothenburg, , Sweden

Hull and East Yorkshire Hospitals NHS Trust

Hull, England, United Kingdom

Guy's and St Thomas' Hospital NHS Trust

London, England, United Kingdom

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

Mid Essex Hospital Services NHS Trust

Broomfield, Essex, United Kingdom

St Helens & Knowsley NHS Trust

St Helens, Mersyside, United Kingdom

Oxford University Hospitals NHS Trust

Headington, Oxford, United Kingdom

North Bristol NHS Trust

Bristol, , United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Royal Devon and Exeter NHS Foundation Trust

Exeter, , United Kingdom

St. James University Hospital

Leeds, , United Kingdom

Royal Free London NHS Foundation Trust

London, , United Kingdom

Imperial College Healthcare NHS Trust

London, , United Kingdom

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Countries

United States; Australia; Canada; Sweden; United Kingdom

References

Temple-Oberle C, Nicholas C, Rojas-Garcia P. Current Controversies in Melanoma Treatment. Plast Reconstr Surg. 2023 Mar 1;151(3):495e-505e. doi: 10.1097/PRS.0000000000009936. Epub 2023 Feb 23.

Reference Type: DERIVED

PMID: 36821575 (View on PubMed)

Related Links

https://www.masc.org.au/active-trials-closed-for-recruitment/

MASC Trials-Closed to recruitment page

Other Identifiers

03.12

Identifier Type: -

Identifier Source: org_study_id

NCT01457157

Identifier Type: -

Identifier Source: nct_alias