Contact information
Type
Scientific
Primary contact
Dr Tim Eisen
ORCID ID
Contact details
Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 1223 40 41 91
tim.eisen@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Sentinel lymph node biopsy feasibility study in patients with primary cutaneous melanoma
Acronym
SLNB
Study hypothesis
To compare the overall and disease-free survival in patients with a positive lymph node at biopsy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Melanoma
Intervention
Completion lymphadenectomy versus no surgery
Intervention type
Other
Phase
Phase II/III
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
13/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients must have clinical stage I or II invasive cutaneous melanoma with Breslow thickness greater than 1.0 mm and be suitable for lymphadenectomy surgery
2. The primary site must be on the trunk, limbs or digits. Patients with a primary melanoma involving the ear, eye or mucous membranes are not eligible.
3. Primary excision must have been within 90 days prior to the initial clinic visit
4. Subjects must be at least 18 years old
5. Karnovsky performance status greater than 70%
6. Women of childbearing age must have a negative pregnancy test
7. Subjects must voluntarily sign an informed consent form before study entry and agree to complete follow-up assessments
8. Adequate bone marrow, renal and hepatic function
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Wide local excision of the primary tumour with greater than 1 cm excision margins before SLNB. Patients may have SLNB and still be eligible for excision margin studies after SLNB.
2. Clinical evidence of satellite, in-transit, regional nodal or distant metastases
3. A second primary invasive melanoma
4. Any malignancy in the past 5 years, except squamous cell carcinoma of the skin, basal cell carcinoma, in situ carcinoma of the uterine cervix, or Stage I laryngeal carcinoma
5. Prior surgery in the region of the primary draining nodal basin that would disrupt normal lymphatic drainage patterns
6. Previous chemotherapy, immunotherapy or radiation therapy
7. Pregnancy or breast feeding
8. Known hypersensitivity to 99mTc-nanocolloid or patent blue dye.
9. History of any severe medical condition that is a significant risk to the participant leading to a life expectancy of less than 10 years prior to diagnosis of melanoma
Recruitment start date
01/09/2002
Recruitment end date
13/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine
Sutton
SM2 5PT
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary