Sentinel lymph node biopsy feasibility study in patients with primary cutaneous melanoma

ISRCTN ISRCTN80602070
DOI https://doi.org/10.1186/ISRCTN80602070
Secondary identifying numbers N/A
Submission date
01/10/2004
Registration date
10/01/2005
Last edited
26/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-to-investigate-the-diagnosis-and-treatment-of-melanoma-skin-cancer-with-sentinel-lymph-node-biopsy

Study website

Contact information

Dr Tim Eisen
Scientific

Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone +44 1223 40 41 91
Email tim.eisen@icr.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleSentinel lymph node biopsy feasibility study in patients with primary cutaneous melanoma
Study acronymSLNB
Study objectivesTo compare the overall and disease-free survival in patients with a positive lymph node at biopsy.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMelanoma
InterventionCompletion lymphadenectomy versus no surgery
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2002
Completion date13/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2002
Date of final enrolment13/10/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom

Sponsor information

Sponsor not defined - Record supplied by Institute of Cancer Research
Not defined

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

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

26/04/2018: No publications found.
23/03/2016: No publications found, verifying study status with principal investigator.