Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

Conditions

• Cutaneous Melanoma, Stage II

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Wide Local Excision = 1cm Margin — PROCEDURE
  A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
• Wide Local Excision = 2cm Margin — PROCEDURE
  A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.

Study Details

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 stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Key Dates

Start date

Dec 17, 2019

Status verified

Nov 2024

Primary completion

Dec 31, 2029

Completion

Dec 31, 2034

Study Design

Enrollment

2,998 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (Wide Local Excision = 1cm Margin)
  1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction
• Active Comparator: Arm B (Wide Local Excision = 2cm Margin)
  2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction

Primary Outcome Measure

Disease-Free Survival [ Time Frame: 0-60 months ]

Central Contacts

• Melanoma and Skin Cancer Trials Coordinator
  +61 3 9903 9022
  [email protected]

Locations (130)

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