Surgery With or Without Lymph Node Mapping and Removal in Treating Patients With Stage I or Stage II Melanoma
|No phase specified||Diagnostic, Treatment||Closed||18 to 75||NCI||JWCI-MORD-MSLT-1193|
I. Determine whether intraoperative lymphatic mapping followed by selective lymphadenectomy in addition to wide excision of the primary melanoma in patients with invasive cutaneous melanoma effectively prolongs disease-free survival and overall survival as compared to patients with wide excision of the primary melanoma alone. II. Assess whether intraoperative lymphatic mapping followed by selective lymphadenectomy can reduce the incidence, time to appearance, and anatomic distribution of distant metastases relative to patients managed by wide excision only. III. Assess the incidence of morbidity in these two treatment groups. IV. Determine whether tumor associated antigen (TAA-90) specific immune complexes are useful in predicting the presence of regional nodal or distant subclinical metastases in clinical Stage I melanoma. V. Compare the incidence of metastases detected in the sentinel nodes with the incidence of subsequent clinically detected metastases in patients treated by wide excision only. VI. Compare the rate of lymph node metastases after wide excision of the primary alone with the rate of lymph node metastases after excision of a microscopically negative sentinel node biopsy. VII. Evaluate the accuracy of lymphatic mapping and selective lymph node dissection in determining the presence of clinically occult regional nodal metastases.
Histologically confirmed Stage IB, IIA, or IIB (excluding satellite lesions) primary invasive cutaneous melanoma that meet one of the following criteria: Clark Level III and Breslow thickness at least 1.00 mm OR Clark Level IV or V with any Breslow thickness Primary cutaneous melanoma site must be on the head, neck, trunk, extremity, scalp, palm of the hand, sole of the foot, or subungual skin No primary cutaneous melanoma involving the eye, ear, or mucous membranes No clinical evidence of satellite lesions or intransit, regional nodal or distant metastases No second primary invasive melanoma
Biologic therapy: No prior immunotherapy Patients receiving wide excision alone: No concurrent interferon alfa as initial treatment Chemotherapy: No prior chemotherapy Endocrine therapy: At least 6 months since prior oral or parenteral steroids Radiotherapy: No prior radiotherapy Surgery: No greater than 10 weeks since biopsy No prior wide excision of the primary at least 3.0 cm in diameter with the shortest tumor-excision margin at least 1.5 cm No prior elliptical excision of the primary with shortest tumor-excision edge at least 1.5 cm No prior organ transplantation consequently requiring immunosuppressive agents No prior skin grafts, tissue transfers or flaps, or lymph node dissection that may alter the lymphatic drainage pattern from a primary cutaneous melanoma to the adjacent regional lymph node basins Other: At least 6 months since any prior immunosuppressive drugs
Age: 18 to 75 Performance status: Not specified Life expectancy: At least 10 years from time of diagnosis, excluding the diagnosis of melanoma Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known primary or secondary immune deficiencies No evidence that patients cannot undergo selective lymph node dissection for any reason No other medical condition that will affect life expectancy No other malignancy in the past 5 years except squamous cell carcinoma of the skin, basal cell carcinoma, or in situ carcinoma of the uterine cervix that has been adequately treated more than 6 months ago for T1 lesions Not pregnant
There will be 1,600 patients accrued into this study (60% into arm I and 40% into arm II).
This is a randomized, prospective, multicenter study. Patients are stratified by primary site (extremity vs nonextremity) and by Breslow thickness (1.20-1.79 mm vs 1.80-3.50 mm). Patients are randomized to receive wide excision with intraoperative lymphatic mapping and selective lymph node dissection (arm I) or wide excision alone (arm II). Patients in arm I undergo preoperative lymphoscintigraphy. Patients with positive lymph nodes after intraoperative lymphatic mapping and selective lymph node dissection undergo complete lymph node dissection. All patients are followed periodically for 10 years.
Trial Lead Organizations
John Wayne Cancer Institute at Saint John's Health Center
|Donald Morton, MD, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.