Surgery Clinical Trial
Official title:
A Randomised Trial of Surgical Excision Margins for Thick Primary Cutaneous Melanoma (>2 mm). A Multicenter Trial Comparing 2-cm vs 4-cm
Verified date | June 1991 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
Objectives: The purpose of this study was to assess the effects of an excision margin of 2
cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM).
Study hypothesis: The hypothesis is that there is no difference between the two treatment
arms measured as overall survival and recurrence free survival.
Status | Completed |
Enrollment | 936 |
Est. completion date | December 2006 |
Est. primary completion date | May 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 75 Years |
Eligibility |
Inclusion Criteria: - Melanoma >2 mm - Age = 75 yr - Patients operated on with = 2-cm at diagnosis - Final surgery planned within 8 weeks after date of diagnosis - Patient fit for surgery - Signed patient consent form Exclusion Criteria: - Melanoma on hand, foot, head-neck or ano-genital regions - The presence of in-transit- regional and/or distant spread of the disease - Illness making patient unfit for surgery - Previous malignancies except basal cell- and in-situ colli uteri cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm Cancer Society, Swedish Cancer Society |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | |||
Secondary | Recurrence free survival |
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