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New treatment option for Cutaneous Melanoma, Stage II
Official title Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
ClinicalTrials.gov ID: NCT03860883
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients may be included in the study if they meet ALL of the following criteria:
- 1\. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness \>1.0mm to 2.0mm; \>2.0mm...
- Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
- An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
- 4\. Surgical intervention (which refers to the staging -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days...
You likely can't join if
- Patients will be excluded from the study for ANY of the following reasons:
- Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
- Patient has already undergone WLE at the site of the primary index lesion.
- Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
- Perineural invasion or neurotropic melanoma: Neurotropism or perineural invasion in any type of melanoma is an exclusion. Perineural invasion does...
- Desmoplastic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of \>90% desmoplasia), they...
See the full eligibility criteria
Who can join
- Patients may be included in the study if they meet ALL of the following criteria:
- 1\. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness \>1.0mm to 2.0mm; \>2.0mm to 4.0mm or \>4.0mm with ulceration, or \>2.0mm to 4.0mm; or \>4.0mm...
- Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
- An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
- 4\. Surgical intervention (which refers to the staging -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days of the original diagnosis. Surgical intervention must also be...
- Patients must be 18 years or older at time of consent.
- Patient must be able to give informed consent and comply with the treatment protocol and follow up plan.
- Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
- Patients must have an ECOG performance score between 0 and 1 at screening.
- 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 (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) with no evidence of...
- The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
What rules you out
- Patients will be excluded from the study for ANY of the following reasons:
- Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
- Patient has already undergone WLE at the site of the primary index lesion.
- Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
- Perineural invasion or neurotropic melanoma: Neurotropism or perineural invasion in any type of melanoma is an exclusion. Perineural invasion does not include entrapment of nerves within the main primary tumour mass.
- Desmoplastic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of \>90% desmoplasia), they are not eligible for this study. However melanomas with less than 90%...
- Microsatellitosis (a nest of metastatic tumour cells found to be growing away from the primary tumour) as per AJCC 8th edition definition is an exclusion.
- Subungual melanoma
- 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. \>1 primary melanoma) invasive melanoma.
- Melanoma located distal to the metacarpophalangeal joint; on the tip of the nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes or internal viscera.
- Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
- Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including -SLNB, of the index melanoma.
- Any additional solid tumour or hematologic malignancy during the past 5 years (with exception of non- melanoma skin cancers (T1 skin lesions of squamous cell carcinoma (SCCs), basal cell carcinoma (BCCs)), or...
- Melanoma-related operative procedures not corresponding to criteria described in the protocol.
- 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.
- History of organ transplantation.
- Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment. Pregnancy is not a specific exclusion criterion for this trial, though it may not be...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Pasadena, California, United States
- San Jose, California, United States
- Vallejo, California, United States
- Walnut Creek, California, United States
- Guilford, Connecticut, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Coral Springs, Florida, United States
- Deerfield Beach, Florida, United States
- Hollywood, Florida, United States
+ 135 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Irvine, California, United States; Los Angeles, California, United States and 149 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.