Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Minimally Invasive Lymph Node Dissection in Treating Patients with Melanoma That Has Spread to the Lymph Nodes

Protocol: OSU-12055

Full Title

Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients with Melanoma

Purpose

This phase I trial studies the safety of a less invasive type of surgery, minimally invasive lymph node dissection, in treating patients with melanoma that has spread to the lymph nodes. Lymph node dissection is a surgical procedure in which the lymph nodes are removed to prevent cancer from growing there or to determine the stage of the cancer. A less invasive lymph node dissection procedure may reduce the risk of complications, reduce healthcare costs, and improve the quality of life of patients. Giving doctors training to teach them how to perform the surgery correctly may help them perform it better.

Study Objective

PRIMARY OBJECTIVES:

I. To evaluate the safety of minimally invasive inguinal lymph node dissection in a phase I multi-institutional feasibility trial.

II. To characterize the learning curve of minimally invasive inguinal lymph node dissection in the clinical setting.

III. To assess if pre-course measures of basic laparoscopic technical skills correlate with post-course minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.

OUTLINE:

Surgeons participate in an educational training program and learn how to perform a minimally invasive lymph node dissection (MILND). Patients then undergo MILND.

After completion of study treatment, patients are followed up at 30 and 90 days.

Are you eligible?

Inclusion Criteria:

Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node (LN) dissection

Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable

Clinical or radiographic evidence of superficial inguinal LN disease or a prior positive sentinel lymph node (SLN) biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable

Patients must be healthy enough to undergo a general anesthetic

Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal >= 1 year (yr)

Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) follow up appointment

Exclusion Criteria:

Prior ipsilateral superficial inguinal lymph node dissection

Invasion or ulceration of inguinal nodal disease into the overlying skin

Prior radiation therapy to the same regional nodal basin

American Society of Anesthesiologists (ASA) class 4 or greater

Melanoma Skin Cancers