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New treatment option for Melanoma (Skin Cancer)
Official title NO Re-excision MelanomA - NORMA 2
ClinicalTrials.gov ID: NCT07530887
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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)
You likely can't join if
- Non-cutaneous melanoma (uveal, mucosal)
- Acral melanoma
- Lentigo malignant melanoma (LMM)
- Desmoplastic melanoma
- Neurotropic melanoma
- Spitz melanoma/malignant Spitz tumor melanoma
See the full eligibility criteria
- 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)
- 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.
- Non-cutaneous melanoma (uveal, mucosal)
- Acral melanoma
- Lentigo malignant melanoma (LMM)
- Desmoplastic melanoma
- Neurotropic melanoma
- Spitz melanoma/malignant Spitz tumor melanoma
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 's-Hertogenbosch, Netherlands
- Alkmaar, Netherlands
- Almere Stad, Netherlands
- Amsterdam, Netherlands
- Apeldoorn, Netherlands
- Arnhem, Netherlands
- Eindhoven, Netherlands
- Enschede, Netherlands
- Gouda, Netherlands
- Groningen, Netherlands
- Hilversum, Netherlands
- Hoorn, Netherlands
- Leiden, Netherlands
- Maastricht, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Utrecht, Netherlands
- Zwolle, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 's-Hertogenbosch, Netherlands; Alkmaar, Netherlands; Almere Stad, Netherlands; Amsterdam, Netherlands; Apeldoorn, Netherlands; Arnhem, Netherlands and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.