Trial of Surgical Excision Margins in Thick Primary Melanoma - 2
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ClinicalTrials.gov Identifier: NCT03638492 |
Recruitment Status :
Completed
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
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Objectives: The purpose of this study was to assess the long-term follow-up of the overall and melanoma-specific survival in the randomised, open-lable multicenter trial (NTC NCT01183936) comparing excision margin of 2 cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM) thicker than 2 mm.
Study hypothesis: The hypothesis is that there is no difference between the two treatment arms measured as melanoma-specific survival and overall survival.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma Surgery Treatment Outcome | Procedure: 2-cm margin Procedure: 4-cm margin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 936 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long-term Follow-up of Survival in Surgical Resected Invasive Cutaneous Melanomas: Comparing 2-cm Versus 4 -cm Resection Margins - a Randomized, Multicenter Trial |
Study Start Date : | January 1992 |
Actual Primary Completion Date : | May 2004 |
Actual Study Completion Date : | December 2006 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 2 cm margin of excision
Patients with CMM >2 mm treated with an excision of 2-cm.
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Procedure: 2-cm margin
Patients with CMM treated with a surgical safety margin of 2-cm in the surrounding skin and down to the fascia. |
Active Comparator: 4 cm margin of excision
Patients with CMM >2 mm treated with an excision of 4-cm.
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Procedure: 4-cm margin
Patients with CMM treated with a surgical safety margin of 4-cm in the surrounding skin and down to the fascia. |
- Melanoma-specific survival [ Time Frame: 24.9 years ]Cause of death: cutaneous malignant melanoma
- Overall survival [ Time Frame: 24.9 years ]Cause of death: all death causes
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Ages Eligible for Study: | up to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638492
Principal Investigator: | Ulrik Ringborg, M.D., Ph.d. | Karolinska inteitutet |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Peter Gillgren, Head of Section for Vascular Surgery, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT03638492 |
Other Study ID Numbers: |
Margins Melanoma -2 Country specific ( Other Identifier: Swe; Nat Reg Nr, Dk; 5 dig ser nr (8XXXX), Ea; 5 dig ser nr (7XXXX), Ny; 4 dig ser nr (9XXX) ) |
First Posted: | August 20, 2018 Key Record Dates |
Last Update Posted: | August 20, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Data could be shared with other researchers in a worldwide meta analysis after the actual study is completed. |
Melanoma/mortality/pathology/*surgery Randomized Controlled Trials as Topic Survival Margin |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neoplasms by Site Skin Diseases |