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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03860883




Registration number
NCT03860883
Ethics application status
Date submitted
7/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019

Titles & IDs
Public title
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma
Scientific title
Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (ANZMTG 02.18 MelMarT-II)
Secondary ID [1] 0 0
ANZMTG 02.18
Universal Trial Number (UTN)
Trial acronym
MelMarT-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma, Stage II 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Wide Local Excision = 1cm Margin
Treatment: Surgery - Wide Local Excision = 2cm Margin

Experimental: Arm A (Wide Local Excision = 1cm Margin) - 1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction

Active Comparator: Arm B (Wide Local Excision = 2cm Margin) - 2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction


Treatment: Surgery: Wide Local Excision = 1cm Margin
A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.

Treatment: Surgery: Wide Local Excision = 2cm Margin
A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival - Time from randomisation to clinically, histologically or radiologically confirmed recurrence of melanoma
Timepoint [1] 0 0
0-60 months
Secondary outcome [1] 0 0
Local Recurrence - Time from randomisation to any clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes
Timepoint [1] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [2] 0 0
Distant Disease-Free Survival - Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma
Timepoint [2] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [3] 0 0
Melanoma-Specific Survival - Time from randomisation to death due to melanoma
Timepoint [3] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [4] 0 0
Overall Survival - Time from randomisation to death from any cause
Timepoint [4] 0 0
Day 0-Trial Completion (max. 120 months)
Secondary outcome [5] 0 0
Melanoma-specific Quality of Life: FACT-M questionnaire - Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire
Timepoint [5] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [6] 0 0
Neuropathic Pain: PainDetect questionnaire - Measured by PainDetect questionnaire
Timepoint [6] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [7] 0 0
Health-related Quality of Life: EQ-5D-5L questionnaire - Measured by EuroQoL EQ-5D-5L questionnaire
Timepoint [7] 0 0
Baseline, 3, 6, 12 & 24 months
Secondary outcome [8] 0 0
Surgery Related Adverse Events - The following surgical adverse events will be recorded from the time of surgery to 30 days following surgery (inclusive):
wound dehiscence
seroma/haematoma
haemorrhage
infection
skin graft failure
necrosis of flap used for reconstruction
deep venous thrombosis
urinary tract infection
pneumonia
cardiac complications
lymphoedema
Timepoint [8] 0 0
Up to 30 days from surgery
Secondary outcome [9] 0 0
Adverse Events - An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness.
Timepoint [9] 0 0
Within 1 year from randomisation
Secondary outcome [10] 0 0
Health Economic Evaluation - Data collected for economic analysis will be from hospital notes, MBS and PBS data (Australia) and patient reported outcome measures (including an employment questionnaire) at baseline, 3, 6, 12 and 24 months and at melanoma recurrence.
Timepoint [10] 0 0
Baseline, 3, 6, 12 & 24 months

Eligibility
Key inclusion criteria
1. Patients must have an invasive primary cutaneous melanoma with Breslow thickness >
2mm, or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition) as determined by
diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent
histopathological analysis.

2. Must have a primary melanoma that is cutaneous (including head, neck, trunk,
extremity, scalp, palm, or sole).

3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary
melanoma.

4. Randomisation and the primary study intervention, including staging sentinel node
biopsy, must be completed within 120 days of the original diagnosis.

5. Patients must be 18 years or older at time of consent.

6. Patient must be able to give informed consent and comply with the treatment protocol
and follow-up plan.

7. Life expectancy of at least 5 years from the time of diagnosis, not considering the
melanoma in question, as determined by the PI.

8. Patients must have an ECOG performance score between 0 and 1.

9. 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,

- There has been no evidence of recurrence of any prior malignancies for at least
FIVE years (except for successfully treated cervical or non-melanoma skin cancer
with no evidence of recurrence), and

- The patient is deemed by their treating physician to be at low risk of recurrence
from previous malignancies.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown
malignant potential'.

2. Patient has already undergone wide local excision at the site of the primary index
lesion.

3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the
primary index lesion.

4. Desmoplastic or neurotropic melanoma.

5. Microsatellitosis as per AJCC 8th edition definition

6. Subungual melanoma

7. Patient has already undergone a local flap reconstruction of the defect after excision
of the primary and determination of an accurate excision margin is impossible.

8. History of previous or concurrent (i.e., second primary) invasive melanoma.

9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the
eyelids or on the ear, mucous membranes or internal viscera.

10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit,
regional, or distant metastatic melanoma.

11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the
probable draining lymphatic field, including sentinel lymph node biopsy, of the index
melanoma.

12. Any additional solid tumour or hematologic malignancy during the past 5 years except
T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical
cancer.

13. Melanoma-related operative procedures not corresponding to criteria described in the
protocol.

14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision
is not permitted as part of the protocol and any patients given this treatment would
be excluded from the study.

15. History of organ transplantation.

16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any
time during study participation or within 6 months prior to enrolment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Sydney
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Norfolk and Norwich University Hospitals NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Patients with a primary invasive melanoma are recommended to undergo excision of the primary
lesion with a wide margin. There is evidence that less radical margins of excision may be
just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of
the primary lesion for adult patients with stage II primary invasive cutaneous melanomas
(AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins
is expected to improve patient quality of life.
Trial website
https://clinicaltrials.gov/show/NCT03860883
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Henderson
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ANZMTG Project Officer
Address 0 0
Country 0 0
Phone 0 0
61 2 9911 7352
Fax 0 0
Email 0 0
melmart@melanoma.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03860883