Health TrialsbyHealthPanel

NO Re-excision MelanomA - NORMA 2

ConditionMelanoma (Skin Cancer)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMarieke Goodijk

About this trial

This multicenter, phase III randomized controlled trial evaluates whether omitting re-excision after complete primary excision of cutaneous melanoma affects patient outcomes. A total of 1,749 patients with pT1b-pT4b cutaneous melanoma without evidence of metastases will be randomized to either standard re-excision according to current guidelines or no re-excision. Sentinel lymph node biopsy and adjuvant systemic therapy will be performed as indicated in both groups.

The primary objective is to compare relapse-free survival (RFS) between the two groups. Secondary objectives include comparisons of overall survival (OS), local recurrence rates, recurrence of in-transit and lymph node metastases, distant metastasis-free survival (DMFS), surgical morbidity, quality of life, and health economic outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be 18 years or older at time of consent

Patients must have an ECOG performance score between 0 and 2

Histologically confirmed, stage pT1b - pT4b (TNM AJCC 8th edition) cutaneous primary melanoma

Superficial Spreading Melanoma (SSM)

Disqualifiers

Non-cutaneous melanoma (uveal, mucosal)

Acral melanoma

Lentigo malignant melanoma (LMM)

Desmoplastic melanoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Re-excision

    Procedure/Surgery

    Prior to the re-excision, before any local anesthetic is given, the margin will be measured by a ruler and marked on the skin of the patient. The melanoma free margin of the diagnostic excision may be subtracted from the re-excision margin. The re-excision should be performed by cutting vertically down along the margins of the re-excision for its entire length until the required margin or until the fascia is reached in the depth. Removal of the fascia is left to the resecting surgeon's discretion. Preservation of anatomical structures, such as veins or nerves is allowed, if they are not clearly involved with tumor. In case of melanoma ≥pT3a any margin between 1 and 2 centimeter is accepted according to the surgeons preference. The amount of margin (in mm) taken during the re-excision needs to be documented perioperatively by the surgeon in the operation report. The specimen should be marked for anatomical navigation and sent off for pathological assessment.

  • No re-excision

    Procedure/Surgery

    In case a patient is randomized toward the no-re-excision treatment arm, there is no need to perform any procedures to the primary tumor site.

Treatment groups

1,749 Participants
are divided into 2 treatment groups
Group A: Arm A (control): re-excisionActive comparator 1 intervention
Group B: Arm B (experimental): no re-excisionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse-Free Survival (RFS)

RFS, defined as time from randomization to any first melanoma recurrence or melanoma-related death, whichever occurs first. Any new primary melanoma and/or melanoma in situ will be registered. However, it will not be considered an event for the primary endpoint of RFS.

Time frame
From randomization to the first occurrence of melanoma recurrence or melanoma-related death, assessed up to 5 years.

Secondary outcomes

1

Overall Survival (OS)

OS, defined as time from randomization to death, no matter what the cause of death was.

Time frame
From randomization to death from any cause, assessed up to 5 years.
2

Local Recurrence Rate (LRR)

LRR, defined as the frequency of local recurrences within the study population. A local recurrence is defined as recurrence within the scar and/or any satellite metastasis within 2 cm.

Time frame
From randomization up to 5 years
3

Recurrence rate of in-transit metastases

Recurrence rate of in-transit metastases, defined as the frequency of in-transit metastasis recurrences within the study population. An in-transit metastasis is defined as any skin or subcutaneous metastasis that occurs more than 2 cm from the primary lesion, but not beyond the regional nodal basin.

Time frame
From randomization up to 5 years
4

Recurrence rate of lymph node metastases

Recurrence rate of lymph node metastases, defined as the frequency of lymph node metastases within the study population.

Time frame
From randomization up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marieke Goodijk

Lead sponsor

The Netherlands Cancer Institute

Sponsor institution

Dutch Cancer Society

Collaborator

Source ClinicalTrials.gov
Apply now