Melanoma (Skin Cancer)Phase 3NORMA-2NCT07530887
NO Re-excision MelanomA - NORMA 2
A Phase 3 study testing Re-excision and No re-excision in people with Melanoma (Skin Cancer), run by Marieke Goodijk at 21 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Re-excision and No re-excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,749 participants
- Where
- 21 sitesNetherlands
- Study dates
- 13 Nov 2025to Nov 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Histological subtypes that are eligible are:
- Superficial Spreading Melanoma (SSM)
- Nodular Melanoma (NM)
Show all 13Show fewer
- The primary melanoma must have been removed by diagnostic excision and must have at least a minimum of 1 mm tumor free margin for invasive melanoma AND any in situ melanoma
- Patient must provide informed consent and comply with the treatment protocol and follow-up plan
- Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator
- A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
- The patient has undergone potentially curative therapy for all prior malignancies
- Life expectancy should be at least 5 years and
- The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
Who cannot join
- Non-cutaneous melanoma (uveal, mucosal)
- Acral melanoma
- Lentigo malignant melanoma (LMM)
- Desmoplastic melanoma
- Neurotropic melanoma
- Spitz melanoma/malignant Spitz tumor melanoma
Show all 16Show fewer
- Satellites, in-transit melanomas or macroscopic melanoma metastases
- Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP)
- Other non-SSM or NM subtypes
- Melanoma removed by shave excision, excogliation or core biopsy
- Patient has already undergone a local flap reconstruction of the defect after excision of the primary
- History of previous or concurrent (i.e., second primary) invasive melanoma
- Multiple melanomas
- Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB
- Any additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 years
- History of organ transplantation
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Netherlands21 sites, 21 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
M. (Maud) Bessems, 073 553 2000, ma.bessems@jbz.nl
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
G. A. (Gea) Gooiker, 072 548 4444, ga.gooiker@nwz.nl
- Recruiting
Flevoziekenhuis
Almere Stad
S. (Sanne) A. L. Bartels, 036 868 8888, sbartels@flevoziekenhuis.nl
- Recruiting
Antoni van Leeuwenhoek
Amsterdam
M. (Marieke). T. Goodijk, MD PhD Candidate, 020 512 2546, norma2@nki.nl
M. (Marieke) T. Goodijk, MD PhD Candidate, 020 512 2546, m.goodijk@nki.nl
- Recruiting
Gelre ziekenhuizen
Apeldoorn
J. (Jens) Homan, 088 105 3300, j.homan@gelre.nl
- Recruiting
Rijnstate Ziekenhuis
Arnhem
N. (Niek) Hugen, 088 005 8888, nhugen@rijnstate.nl
- Not yet recruiting
Catharina ziekenhuis
Eindhoven
G. (Grard) A. P. Nieuwenhuijzen, 040 239 9111, grard.nieuwenhuijzen@catharinaziekenhuis.nl
- Recruiting
Medisch Spectrum Twente
Enschede
A.E. (Anneriet) Dassen, 053 487 2000, a.dassen@mst.nl
- Not yet recruiting
Groene Hart Ziekenhuis
Gouda
A. (Anne) van Beurden, 0182 505 050, anne.van.beurden@ghz.nl
- Not yet recruiting
Martini ziekenhuis
Groningen
H.A. (Henriette) Schuttevaer, 050 524 5245, henriette.schuttevaer@mzh.nl
- Not yet recruiting
Tergooi MC
Hilversum
A.A. (Alwine) Hellingman, 088 753 1753, ahellingman@tergooi.nl
- Not yet recruiting
Dijklander Ziekenhuis
Hoorn
D.J.A. (Eric) Sonneveld, 0229 257 257, d.j.a.sonneveld@dijklander.nl
- Not yet recruiting
Alrijne Ziekenhuis
Leiden
C.C. (Carmen) van der Pol, 071 582 8282, ccvanderpol@alrijne.nl
- Recruiting
Leids Universitair Medisch Centrum
Leiden
J. (Jos) A. van der Hage, 071 526 9111, j.a.van_der_hage@lumc.nl
- Not yet recruiting
Maastricht UMC
Maastricht
K.B.M.I. (Kristien) Keymeulen, 043 387 6543, k.keymeulen@mumc.nl
- Not yet recruiting
Maasstad Ziekenhuis
Rotterdam
A.M.M.J. (Annique) Pieters, 010 291 1911, pietersA@maasstadziekenhuis.nl
- Recruiting
Haaglanden Medisch Centrum
The Hague
M. (Marieke) E. Straver, 088 979 7900, m.straver@haaglandenmc.nl
- Not yet recruiting
Haga Ziekenhuis
The Hague
I. (Ilse) Jannink, 070 210 0000, i.jannink@hagaziekenhuis.nl
- Recruiting
Diakonessenhuis
Utrecht
B. (Barbara) Molenkamp, 088 250 5000, bmolenkamp@diakhuis.nl
- Not yet recruiting
St. Antonius Ziekenhuis
Utrecht
E.L. (Emily) Postma, 088 320 3000, e.postma@antoniusziekenhuis.nl
- Not yet recruiting
Isala Ziekenhuis
Zwolle
A.B. (Anne-Brecht) Francken, 088 624 5000, a.b.francken@isala.nl
About this study
Official title: Multicenter Phase 3 Randomized Controlled Trial of NO Re-excision MelanomA - NORMA 2
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.
Read the detailed description
This multicenter, phase III randomized controlled non-inferiority trial evaluates the oncologic safety and clinical impact of omitting re-excision after complete diagnostic excision of primary cutaneous melanoma. Although current guidelines recommend re-excision with margins of 1-2 cm depending on Breslow thickness, the clinical benefit of this procedure in all patients remains uncertain.
Patients with histologically confirmed pT1b-pT4b (AJCC 8th edition) cutaneous melanoma who have undergone complete primary excision with tumor-free margins and show no evidence of regional or distant metastases will be randomized in a 1:1 ratio to either standard re-excision according to local protocols (control arm) or omission of re-excision (experimental arm). Sentinel lymph node biopsy (SLNB) will be performed according to current guidelines and local practice, and may be omitted in selected patients at the discretion of the treating physician. Randomization will be stratified by tumor T stage and SLNB status and adjuvant systemic therapy is permitted according to national guidelines.
Re-excision, when performed, should take place within 12 weeks of the initial diagnostic excision and follow standardized surgical principles, including documentation of surgical margins and pathological assessment of the specimen. Patients will be followed for up to 5 years according to current clinical guidelines. Recurrences will be categorized as local, in-transit, nodal, or distant, and histological confirmation will be obtained whenever feasible. Management of recurrences and use of systemic therapies will be at the discretion of the treating physicians and recorded throughout the study.
In addition to oncologic outcomes, the study evaluates surgical morbidity, including postoperative complications classified according to the Clavien-Dindo system and the need for reconstructive procedures. Patient-reported outcomes will be collected longitudinally to assess health-related quality of life and scar-related outcomes using validated questionnaires. Health economic evaluation will include cost-effectiveness and cost-utility analyses from healthcare and societal perspectives, incorporating resource use, productivity losses, and quality-adjusted life years over a lifetime horizon using model-based approaches.
The trial is designed as a non-inferiority study to compare relapse-free survival between re-excision and no re-excision. The sample size is sufficient to detect non-inferiority with respect to a predefined margin, corresponding to an acceptable absolute decrease in 5-year relapse-free survival of 5%. Time-to-event endpoints will be analyzed using Kaplan-Meier methods and Cox proportional hazards models adjusted for stratification factors, with hazard ratios and 90% confidence intervals reported. The primary analysis will follow the intention-to-treat principle, with a supportive per-protocol analysis. Secondary endpoints will be analyzed using appropriate regression methods for time-to-event and binary outcomes, and longitudinal patient-reported outcomes will be evaluated using mixed-effects models. Sensitivity analyses will assess the potential influence of adjuvant systemic therapy on outcomes. An interim analysis for futility is planned after a subset of events has occurred.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Re-excision, No re-excision
- Keywords
- primary cutaneous melanoma, re-excision, de-escalation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-excisionProcedure or 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-excisionProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (control): re-excision | Active comparator | Re-excision (according to local protocol between 1 and 2 cm margins) Receives: Procedure: Re-excision |
| Arm B (experimental): no re-excision | Experimental | No re-excision Receives: Procedure: No re-excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to the first occurrence of melanoma recurrence or melanoma-related death, assessed up to 5 years.
Secondary outcomes (13)
Overall Survival (OS)
OS, defined as time from randomization to death, no matter what the cause of death was.
Measured: From randomization to death from any cause, assessed up to 5 years.
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.
Measured: From randomization up to 5 years
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.
Measured: From randomization up to 5 years
Recurrence rate of lymph node metastases
Recurrence rate of lymph node metastases, defined as the frequency of lymph node metastases within the study population.
Measured: From randomization up to 5 years
Distant Metastasis-Free Survival (DMFS)
DMFS, defined as time from randomization until the occurrence of a distant metastasis.
Measured: From randomization to the first occurrence of distant metastasis, assessed up to 5 years
Surgical complication rates
Surgical complication rates according to Clavien-Dindo surgical classification and frequency of reconstructive surgery.
Measured: From the date of surgery up to 30 days post-surgery
Quality of Life (EORTC QLQ-C30)
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, with higher scores indicating better functioning and quality of life (for functional scales) and worse symptoms (for symptom scales).
Measured: Baseline, 3, 6, 12, and 24 months.
Quality of Life (FACT-M Melanoma Surgery Scale)
Quality of life assessed using the Functional Assessment of Cancer Therapy - Melanoma (FACT-M). Scores range from 0 to 96 with higher scores indicating worse quality of life.
Measured: Baseline, 3, 6, 12, and 24 months.
Quality of Life (Cancer Worry Scale)
Cancer related worry assessed using the 8 item Cancer Worry Scale (CWS). Each item is scored on a 4 point scale ranging from 1 (not at all) to 4 (very much). Total scores range from 8 to 32, with higher scores indicating greater cancer-related worry.
Measured: Baseline, 3, 6, 12, and 24 months.
Quality of Life (POSAS)
Subjective scar quality assessed by the patient using the Patient and Observer Scar Assessment Scale (POSAS), patient component. The patient scale consists of 18 items scored on a 5 point scale (1 = not relevant, 5 = extremely relevant). Total scores range from 18 to 90, with higher scores indicating worse scar quality.
Measured: 3 and 12 months after randomization.
Health Technology Assessment (EQ-5D-5L)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The instrument includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses are converted into a utility index score ranging from less than 0 (worse than death) to 1 (full health), with higher scores indicating better health status.
Additionally, patients rate their overall health on a visual analogue scale (EQ VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health.
Measured: 3, 6, and 12 months after randomization.
Health Technology Assessment (iMCQ)
Healthcare utilization assessed using the iMTA Medical Consumption Questionnaire (iMCQ). This questionnaire measures medical resource use over the past 3 months, including contacts with healthcare providers (e.g., general practitioner, specialists, therapists), hospital admissions, emergency visits, medication use, and informal care. Resource use is reported as frequencies (e.g., number of visits, days, or hours). Higher values indicate greater healthcare utilization.
Measured: 3, 6, and 12 months after randomization.
Health Technology Assessment (iPCQ)
Productivity losses assessed using the iMTA Productivity Cost Questionnaire (iPCQ). This questionnaire measures productivity losses over the past 3 months, including absenteeism (days absent from paid work), presenteeism (reduced productivity while at work, scored on a scale from 0 [unable to work] to 10 [normal productivity]), and losses in unpaid work. Higher values indicate greater productivity loss.
Measured: 3, 6, and 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start13 Nov 2025
- Primary completionNov 2033 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,749 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marieke Goodijk
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor-investigator, Marieke Goodijk, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530887
- Sponsor's protocol ID
- NetherlandCI
- Other IDs
- NL-OMON57910
- Acronym
- NORMA-2
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase 3 Randomized Controlled Trial of NO Re-excision MelanomA - NORMA 2
- ClinicalTrials.gov ID
- NCT07530887
- Acronym / sponsor ID
- NORMA-2 / NetherlandCI
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- primary cutaneous melanoma, re-excision, de-escalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,749 participants (estimated)
- Lead sponsor
- Marieke GoodijkUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Nov 2033 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter, phase III randomized controlled non-inferiority trial evaluates the oncologic safety and clinical impact of omitting re-excision after complete diagnostic excision of primary cutaneous melanoma. Although current guidelines recommend re-excision with margins of 1-2 cm depending on Breslow thickness, the clinical benefit of this procedure in all patients remains uncertain.
Patients with histologically confirmed pT1b-pT4b (AJCC 8th edition) cutaneous melanoma who have undergone complete primary excision with tumor-free margins and show no evidence of regional or distant metastases will be randomized in a 1:1 ratio to either standard re-excision according to local protocols (control arm) or omission of re-excision (experimental arm). Sentinel lymph node biopsy (SLNB) will be performed according to current guidelines and local practice, and may be omitted in selected patients at the discretion of the treating physician. Randomization will be stratified by tumor T stage and SLNB status and adjuvant systemic therapy is permitted according to national guidelines.
Re-excision, when performed, should take place within 12 weeks of the initial diagnostic excision and follow standardized surgical principles, including documentation of surgical margins and pathological assessment of the specimen. Patients will be followed for up to 5 years according to current clinical guidelines. Recurrences will be categorized as local, in-transit, nodal, or distant, and histological confirmation will be obtained whenever feasible. Management of recurrences and use of systemic therapies will be at the discretion of the treating physicians and recorded throughout the study.
In addition to oncologic outcomes, the study evaluates surgical morbidity, including postoperative complications classified according to the Clavien-Dindo system and the need for reconstructive procedures. Patient-reported outcomes will be collected longitudinally to assess health-related quality of life and scar-related outcomes using validated questionnaires. Health economic evaluation will include cost-effectiveness and cost-utility analyses from healthcare and societal perspectives, incorporating resource use, productivity losses, and quality-adjusted life years over a lifetime horizon using model-based approaches.
The trial is designed as a non-inferiority study to compare relapse-free survival between re-excision and no re-excision. The sample size is sufficient to detect non-inferiority with respect to a predefined margin, corresponding to an acceptable absolute decrease in 5-year relapse-free survival of 5%. Time-to-event endpoints will be analyzed using Kaplan-Meier methods and Cox proportional hazards models adjusted for stratification factors, with hazard ratios and 90% confidence intervals reported. The primary analysis will follow the intention-to-treat principle, with a supportive per-protocol analysis. Secondary endpoints will be analyzed using appropriate regression methods for time-to-event and binary outcomes, and longitudinal patient-reported outcomes will be evaluated using mixed-effects models. Sensitivity analyses will assess the potential influence of adjuvant systemic therapy on outcomes. An interim analysis for futility is planned after a subset of events has occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (control): re-excision | Active comparator | Procedure: Re-excisionRe-excision (according to local protocol between 1 and 2 cm margins) |
| Arm B (experimental): no re-excision | Experimental | Procedure: No re-excisionNo re-excision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Histological subtypes that are eligible are:
- The primary melanoma must have been removed by diagnostic excision and must have at least a minimum of 1 mm tumor free margin for invasive melanoma AND any in situ melanoma
Key exclusion criteria (16 listed)
- Non-cutaneous melanoma (uveal, mucosal)
- Acral melanoma
- Lentigo malignant melanoma (LMM)
- Desmoplastic melanoma
- Neurotropic melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-excisionPrior 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. | Procedure or surgery | Arm A (control): re-excision |
| No re-excisionIn 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. | Procedure or surgery | Arm B (experimental): no re-excision |
Primary outcome
Relapse-Free Survival (RFS)
Time frame: From randomization to the first occurrence of melanoma recurrence or melanoma-related death, assessed up to 5 years.
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.
13 secondary outcomes
Overall Survival (OS)
Time frame: From randomization to death from any cause, assessed up to 5 years.
Local Recurrence Rate (LRR)
Time frame: From randomization up to 5 years
Recurrence rate of in-transit metastases
Time frame: From randomization up to 5 years
Recurrence rate of lymph node metastases
Time frame: From randomization up to 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: From randomization to the first occurrence of distant metastasis, assessed up to 5 years
Surgical complication rates
Time frame: From the date of surgery up to 30 days post-surgery
Quality of Life (EORTC QLQ-C30)
Time frame: Baseline, 3, 6, 12, and 24 months.
Quality of Life (FACT-M Melanoma Surgery Scale)
Time frame: Baseline, 3, 6, 12, and 24 months.
Quality of Life (Cancer Worry Scale)
Time frame: Baseline, 3, 6, 12, and 24 months.
Quality of Life (POSAS)
Time frame: 3 and 12 months after randomization.
Health Technology Assessment (EQ-5D-5L)
Time frame: 3, 6, and 12 months after randomization.
Health Technology Assessment (iMCQ)
Time frame: 3, 6, and 12 months after randomization.
Health Technology Assessment (iPCQ)
Time frame: 3, 6, and 12 months after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Website Antoni van Leeuwenhoek NORMA 2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Re-excision and No re-excision in people with Melanoma (Skin Cancer), run by Marieke Goodijk at 21 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Y. (Yvonne) M. Schrage, MD PhD (020 512 9111, y.schrage@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) (time frame: From randomization to the first occurrence of melanoma recurrence or melanoma-related death, assessed up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 4 Nov 2026.