Clinical Trial Details
A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
Overview
Can we treat your melanoma just as effectively without doing a sentinel lymph node (SLN) biopsy in addition to your wide local excision (WLE) procedure? A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue. This is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well.
We are doing this study because we want to find out if performing the WLE alone is just as effective as the usual approach for your melanoma, and if it leads to improvements in patients' overall well-being. The usual approach is defined as care most people get for the early stage of melanoma that you currently have.
Eligibility
| Ages | 75 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Older Adult |
Inclusion Criteria:
- Patient must be ≥ 75 years of age.
- Patient must have ECOG Performance Status of 0-2.
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
- Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the treating physician, pending definitive surgical management.
- Patient must be eligible for WLE and SLN biopsy. Patients for whom SLN biopsy would be contraindicated, difficult to perform (i.e., after prior surgery in the draining basin) or impossible (i.e., after prior lymphadenectomy for another cause) are not eligible.
- Patient must be eligible for surgery and not have uncontrolled medical condition that in the opinion of the medical or surgical oncologist precludes surgical management.
- Patient must be English or Spanish speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs). Patients who speak only French can be enrolled in Canada and appropriate documents will be made available by the study team.
Exclusion Criteria:
- Patient must not have an active infection that precludes enrollment to this study in opinion of treating investigator.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
