Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II)

Phase 3

Recruiting

Conditions: disease free survival
Excision margin
10040795

Registration Number: NL-OMON54102

Lead Sponsor: Melanoma and Skin Cancer Trials Limited, Melbourne Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

1. Patients must have a stage II primary invasive cutaneous melanoma with
Breslow thickness 2.01mm to 4mm or >4mm with or without ulceration (pT3a-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. Surgical intervention (which refers to SLNB and WLE as these are both to be
done on the same day), 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 at screening.
9. A survivor of prior cancer is eligible provided that ALL of the following
criteria are met and documented:
o The patient has undergone potentially curative therapy for all prior
malignancies,
o There has been no evidence of recurrence of any prior malignancies
for at least FIVE years (with the exception if successfully treated
uterine/cervical or non-melanoma skin cancers
(SCCs/BCCs with no evidence of recurrence), and
o The patient is deemed by their treating physician to be at low risk
of recurrence from previous malignancies.

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: with any patient where pathology
determines melanoma as PURE desmoplastic (as per WHO definition of >90%
desmoplasia),
they are not eligible for this study. However other melanomas with less
than 90% desmoplasia or mixed subtypes are eligible unless there is
neurotropism present (peri
neural invasion). Neurotropism in any type of melanoma is an exclusion.
Peri-neural invasion does not include entrapment of nerves within the main
primary tumour
mass*.
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; genitalia, perineum or anus; 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 (with exception of non-melanoma skin cancers (T1 skin lesions of squamous
cell
carcinoma (SCCs), basal cell carcinoma (BCC*s)), 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 enrolment or within 6 months prior to enrolment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Disease-Free Survival: Time from randomisation until the first clinically,<br /><br>histologically or radiologically confirmed recurrence of melanoma at any body<br /><br>site, or death from any cause. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Local recurrence: time from randomisation to any clinically, histologically<br /><br>or radiologically confirmed local recurrence of melanoma including satellite<br /><br>lesions and in transit metastases between the primary site and the regional<br /><br>draining lymph nodes<br /><br>2. Distant Disease-free survival: time from randomisation to any clinically,<br /><br>histologically or radiologically confirmed distant recurrence of melanoma<br /><br>3. Melanoma specific survival: Time from randomisation to death due to melanoma<br /><br>4. Overall Survival: time from randomisation to death from any cause.<br /><br>5. QoL and neuropathic pain assessments at baseline, 3, 6, 12 and 24 and at<br /><br>melanoma recurrence.<br /><br>6. Surgery related adverse events up to 30 days from the date of surgery.<br /><br>7. Adverse events within 1 year<br /><br>8. Health economic evaluation resource utilisation and cost-utility analysis</p><br>