Trial comparing treatments for Cutaneous Melanoma
Official title Comparing the Effectiveness of Less Invasive Procedures With the Current Standard of Care for the Treatment of Older Adults With Early-Stage Melanoma
ClinicalTrials.gov ID: NCT07068074
What this study is testing
- What it's testing
- This phase III trial compares the effect of wide local excision (WLE) alone to usual care with WLE plus sentinel lymph node (SLN) biopsy for the treatment of older adults with early-stage melanoma. A WLE is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- Patient must be ≥ 75 years of age.
- Patient must have Eastern Cooperative Oncology Group (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...
- Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) biopsy indicated per the...
- NOTE: For WLE and SLN to be indicated, the patient must have either:
See the full eligibility criteria
- Patient must be ≥ 75 years of age.
- Patient must have Eastern Cooperative Oncology Group (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...
- 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.
- NOTE: For WLE and SLN to be indicated, the patient must have either:
- Pathologic features that include ≧ Breslow 0.8 mm OR Breslow \ 1 mitosis/mm\^2. OR
- Risk of SLN metastasis of at least 5%, as calculated using the Melanoma Institute of Australia (MIA) Sentinel Node Metastasis Prediction Tool.
- 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...
- 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 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- Patient must be English speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs).
- NOTE: Sites cannot translate the associated quality of life (QOL) forms.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Arroyo Grande, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Merced, California, United States
- Orange, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Luis Obispo, California, United States
- Santa Maria, California, United States
+ 125 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Daphne, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Fairbanks, Alaska, United States and 139 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.