A Phase 3 interventional study of Adjuvant Therapy and Comprehensive Geriatric Assessment in Cutaneous Melanoma, sponsored by ECOG-ACRIN Cancer Research Group. Recruiting at 181 sites in United States. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by ECOG-ACRIN Cancer Research Group · Phase 3, Interventional, and Treatment
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. This is sometimes followed by a SLN biopsy, in which lymph nodes that tumor cells could spread to are removed as well. Using WLE alone may be just as effective as usual care in treating older adults with early-stage melanoma.
PRIMARY OBJECTIVES:
I. To evaluate and compare 2-year recurrence-free survival (RFS) rates in both study arms.
II. To evaluate patient-reported outcomes (PRO) at 2 years (as measured by the change in Functional Assessment of Cancer Therapy-Melanoma [FACT-M] total score) in both study arms.
SECONDARY OBJECTIVES:
I. To evaluate and compare RFS, overall survival (OS), melanoma-specific survival (MSS), safety and PRO (at various endpoints).
II. To evaluate the correlation between practical geriatric assessment (PGA) findings at baseline by domain and study outcomes including RFS, OS, MSS.
III. To evaluate the correlation between changes in PGA scores over the study period and study outcomes including RFS, OS, MSS.
IV. To use the baseline and follow up geriatric assessment (GA) data to develop an assessment tool to allow for future risk assessment for older adults with early-stage melanoma to guide the decision regarding surgical approach.
V. To validate the practical geriatric assessment instrument with data obtained from this study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT or ultrasound throughout the study.
ARM B: Patients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study.
After completion of study treatment, patients are followed up every 4 months for 2 years post-randomization and then every 6 months until 5 years post-randomization.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 428 is above the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →ECOG-ACRIN Cancer Research Group is the lead sponsor of 122 studies on the registry; 16 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patient must have newly diagnosed primary cutaneous melanoma with wide local excision (WLE) and sentinel lymph node (SLN) indicated per the treating physician, pending definitive surgical management.
NOTE: For WLE and SLN to be indicated, the patient must have either:
OR
Risk of SLN of at least 5%, as calculated using the Melanoma Institute of Australia (MIA) Sentinel Node Metastasis Prediction Tool.
Patient must be English speaking to be eligible for this study in order to complete the patient-reported outcomes (PROs).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo WLE plus SLN biopsy and may undergo surveillance of nodal basin as usual care on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study.
Procedure: Adjuvant Therapy · Other: Comprehensive Geriatric Assessment · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Procedure: Sentinel Lymph Node Biopsy · Behavioral: Surveillance · Procedure: Ultrasound Imaging · Procedure: Wide Local Excision
Patients undergo WLE and surveillance of nodal basin on study. Patients may receive adjuvant therapy as clinically indicated. Additionally, patients may undergo CT, PET/CT or ultrasound throughout the study.
Procedure: Adjuvant Therapy · Other: Comprehensive Geriatric Assessment · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Other: Questionnaire Administration · Behavioral: Surveillance · Procedure: Ultrasound Imaging · Procedure: Wide Local Excision
Receive adjuvant therapy
Also known as: adjunct therapy, adjunctive therapy, AJ-Adjuvant Therapy
Ancillary studies
Undergo CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Ancillary studies
Undergo SLN biopsy
Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo surveillance of nodal basin
Also known as: Epidemiology / Surveillance
Undergo ultrasound
Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US
Undergo WLE
Also known as: Wide Resection
Recurrence free survival (RFS) rate
Will evaluate RFS rate. Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. The 2-year RFS rate will be estimated from the Kaplan-Meier curve and compared between treatment arms via two sample binomial test, and the 95% confidence interval (CI) will be provided. Will be measured on the intention-to-treat patient cohort. Patients that have not had an event reported at analysis will be censored at their date of last follow-up. Patients who drop out or are lost to follow up before 2 years will be censored.
Time frame: From randomization to recurrence of disease or death from any cause, assessed at 2 years
Patient reported outcome (PRO)
Will compare the co-primary endpoints in a hierarchical manner starting with RFS rate. If RFS rate in non-inferior (wide local incision \[WLE\] is non-inferior to WLE plus sentinel lymph node biopsy) will proceed to evaluate PRO as a co-primary endpoint. Will measure patients quality of life by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) score. The FACT-M score change will be calculated by FACT-M score at 2 years minus the FACT-M score at baseline. Descriptive analyses will be conducted for baseline scores, 2-year scores and the change. The change scores will be compared between the two study arms with two sample t test. 95% CI will be provided. If RFS rate is inferior will proceed to evaluate PRO as an exploratory endpoint.
Time frame: Baseline to 2 years
RFS
Will evaluate RFS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years.
Time frame: From randomization to recurrence of disease or death from any cause, assessed up to 2 years
Overall Survival (OS)
Will evaluate OS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years.
Time frame: From randomization to death from any cause, assessed up to 2 years
Melanoma-specific survival (MSS)
Will evaluate MSS. Will be measured on the intention-to-treat patient cohort. Survival analyses will be performed using the Kaplan-Meier curve and compared between the two treatment arms by stratified log-rank test. Estimates at 2 years will be summarized along with median time for those events that reach a median survival at or before 2 years. Patients who have not died will be censored at the date last known to be alive.
Time frame: From randomization to death due to melanoma, assessed up to 2 years
Incidence of adverse events (AEs)
Will evaluate AEs. All subjects will be included in the safety analysis, with toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events. Incidence tables will be generated to summarize incidence of patients reporting at least one episode of each specific AE, incidence of AEs causing withdrawals and incidence of serious AEs. Listing of AEs by patients will include the time to onset, the duration of each event, the severity of each event, and the relationship of the event to study therapy, whether it was a serious event, and whether it caused withdrawal.
Time frame: Baseline to after surgery
PRO
Will evaluate PRO. Quality of life questionnaires will be scored and summarized at each timepoint within and after 2 years. Parametric assumptions will be assessed using Shapiro-Wilk statistics and qqplots and non-parametric alternatives will be considered when necessary. Scores will be analyzed using an appropriate longitudinal modeling approach (e.g., mixed-effects linear modeling assuming normality of scores) to compare patterns over time between treatment groups.
Time frame: Up to 5 years
Geriatric factors
Will analyze geriatric factors evaluated by the baseline practical geriatric assessment domains, to better understand factors affecting older adults diagnosed with localized melanoma. Will investigate the associations of survival outcomes and practical geriatric assessment scores by domains. Will use Cronbach's alpha test to test for an internal consistency for each domain. Will also use the intra-class correlation test to assess the level of agreement of each domain score at different timepoints. Will use Cohen's kappa test to test the agreement over different timepoints for specific items of interest.
Time frame: Baseline to 5 years
Treatment effect
Will estimate treatment effect and the corresponding 95% CIs if computable.
Time frame: Up to 5 years
Primary outcome treatment effect
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by sex.
Time frame: Up to 5 years
Primary outcome treatment effect
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by race.
Time frame: Up to 5 years
Primary outcome treatment effect
Will estimate the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.
Time frame: Up to 5 years
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Started Apr 2026 (actual). Primary completion is estimated for Jan 2031, 56 months after the start.
Of 95 phase 3 interventional studies under Melanoma, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 94. This study's planned 56 months is above that.
How these figures are worked out, and which studies are left out of them.
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