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

Phase 2

Completed

• Conditions: Melanoma; Cancer

• Registration Number: ISRCTN80602070
• Lead Sponsor: Sponsor not defined - Record supplied by Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-01-10
• Study Completion: 2006-10-13
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration