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

What is the Purpose of this Study?

This study focuses on individuals who have been diagnosed with a form of skin cancer called melanoma, which develops from melanocytes (pigment cells). During surgery for melanoma, the skin cancer and a small margin of healthy tissue around it are removed. This study will evaluate how much skin should be removed from around the melanoma. Specifically, researchers will compare the usual surgery (with a 2-cm margin) to surgery with a 1-cm margin. The use of the 1-cm margin skin removal approach may cause fewer side effects and improve quality of life. The study will evaluate how long after surgery it takes for melanoma to return, as well as any side effects of the 2 approaches. Participants will be randomly assigned to undergo surgery with a 1-cm margin or surgery with a 2-cm margin. All participants will also have a sentinel lymph node biopsy (SLNB), which is a staging procedure and routine part of treatment.

Eligibility

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.

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.

Show less

Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute : Saba Mukarram
Huntington Cancer Center, an Affiliate of Cedars-Sinai Cancer

More about this Clinical Trial

What is the full name of this clinical trial?

S2015: Melanoma Margins Trial A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma,

Study Details

Disease Type/Condition

Melanoma

Principal Investigator

Faries, Mark

Co-Investigators

Alicia Terando, Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Marc Attiyeh, Navid Hafez, Omid Hamid, Trevan Fischer

Age Group

Adult

Phase

III

IRB Number

STUDY00002396

ClinicalTrials.gov ID

NCT02385214

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Saba Mukarram

Phone

+1 310-231-2181

MukarramS@cshs.org