Condition category
Cancer
Date applied
01/10/2004
Date assigned
10/01/2005
Last edited
23/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Sponsor not defined - Record supplied by Institute of Cancer Research

Sponsor details

Institute of Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

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

Publication citations

Additional files

Editorial Notes

23/03/2016: No publications found, verifying study status with principal investigator.