Please follow this link to see a simplified discussion of this trial...CLICK HERE

This is a prospective, phase III, randomised trial for the evaluation of therapeutic treatment of
sentinel lymph node biopsy POSITIVE patients with cutaneous melanoma. If the subject is sentinel node positive and meets study requirements, the subject is randomized to receive either:
  1. completion lymphadenectomy (see axillary dissection, groin dissection or neck dissection)
  2. observation with nodal ultrasound
Inclusion Criteria:
1. Ability to provide informed consent.
2. Between 18 and 75 years of age.
3. Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues).
4. Have clear margins following wider local excision.
5. ECOG performance status 0-1 -
essentially means patients without serious medical conditions (your doctor will advise)
6. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator.
7. Willing to return to the MSLT-II center
(in this case, Norwich) for follow up examinations and procedures as outlined in the protocol.
8. Randomization and/or Completion Lymph Node Dissection, ie. Surgery, (as appropriate to randomization arm) must be completed no more than 120 days following the diagnostic biopsy of the primary melanoma.
9. Have a melanoma-related tumor-positive sentinel node, determined by either of the following methods:
a. Diagnosis of tumor-positive sentinel node by MSLT-II center institutional pathologist by special stains.
Exclusion Criteria:
1. History of previous or concurrent (i.e., second primary) invasive melanoma.
2. Primary melanoma of the eye, ears, mucous membranes or internal viscera.
3. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic disease.
4. Any additional solid tumor or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine cervical cancer.
5. Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to a lymph node basin.
6. Allergy to vital blue dye or any radiocolloid.
7. Inability to localize 1-2 sentinel node drainage basins via lymphatic mapping (e.g., no basins found, more than 2 basins found, proximity of the primary melanoma to the regional draining basin, etc.)
8. Completion Lymph Node Dissection or
sentinel lymph node biopsy (before evaluation of the current melanoma) that may have altered the lymphatic drainage pattern from the primary cutaneous melanoma to a potential lymph node basin.
9. Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, or be exacerbated by therapy (e.g., severe depression).
10. Melanoma-related operative procedures not corresponding to criteria described in the protocol.
11. Primary or secondary immune deficiencies or known significant autoimmune disease.
12. History of organ transplantation.
13. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrollment.
14. Pregnant or lactating women.
15. Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.

Study Centre: NNUH - patients will have to travel to Norwich to participate
Follow-Up: 10 years
Study arms: 2 (
Surgery versus Observation with ultrasound)

Links and further information:

1. Patient Consent and Information sheet:
2. MSLT-II QOL Full - Questionnaire
3. MSLT-II MOS Full - Questionnaire
4. Day 0 - QOL
5. Simplified version of this webpage on CancerHelp UK
UA-20538698-1 GSN-264747-I