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

Summary

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.


Inclusion Criteria

  • Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2mm without ulceration), or >1mm (with ulceration only) (pT2b-pT4b, AJCC 8th edition) as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
  • 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.
  • Surgery (which refers to the staging sentinel node biopsy and wide local excision as these are both to be done on the same day) must be completed within 120 days of the original diagnosis.
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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

Full Title

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,

Details
Disease Type/Condition

Melanoma

Principal Investigator

Faries, Mark

Co-Investigators

Inderjit Mehmi, Katelyn Atkins, Omid Hamid

Age Group

Adult

Phase

III

IRB Number

STUDY00002396

ClinicalTrials.gov ID

NCT03860883

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Melanoma

Principal Investigator

Faries, Mark

Age Group

Adult

Phase

III

IRB Number

S2015

ClinicalTrials.gov ID

NCT03860883

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Want to join the study or
learn more?