ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Local recurrence rate
研究概览
简要总结
This clinical trial compares the effect of a narrow surgical excision (removal) to a wide excision for the treatment of adults with invasive cutaneous melanoma. Currently the standard of care is to take wide margins (boarder of healthy tissue surrounding the melanoma) when removing melanoma. Narrow margin excision removes a smaller amount of healthy tissue when surgically removing the melanoma. Narrow margin excision may be effective in removing the melanoma while also reducing surgical complications and improving quality of life for adults with invasive cutaneous melanoma.
详细描述
PRIMARY OBJECTIVE:
I. To compare the 3-year local recurrence-free survival rates (RFS) in melanoma patients treated with narrow excision versus (vs) wide excision.
SECONDARY OBJECTIVES:
I. To measure the 3-, 5-year Regional (nodal) disease-free survival (DFS) in melanoma patients treated with active nodal surveillance.
II. To compare 5-year local recurrence-free survival in patients treated with narrow vs wide excision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
- •Age ≥ 18 years; all biological gender identities and racial/ethnic groups will be included
- •Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible.
- •Participants must have one of the following:
- •American Joint Committee on Cancer (AJCC) 8th Ed clinical stage IA disease with Breslow thickness > 0.5 mm AND at least one high-risk feature (Mitotic rate ≥ 2/mm2, age ≤ 42, lymphovascular invasion, head/neck location)
- •AJCC 8th Ed Clinical Stage IB melanoma
- •If a melanoma is widely transected and the true Breslow depth is uncertain, then to be eligible for this trial, the melanoma must be re-biopsied to ascertain an accurate Breslow depth.
- •The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)
- •Study intervention (surgery) must be completed within 120 days of the original diagnostic biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
- •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
- •Participants with a history of HIV infection are eligible
- •Participants can speak, read and write in English or Spanish
排除标准
- •Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
- •The patient has already undergone wide local excision at the site of the primary index lesion
- •The patient has a pure desmoplastic melanoma. A pure desmoplastic melanoma is defined as being > 90% desmoplastic type. Melanomas with < 90% desmoplastic type may be included in this trial
- •Mucosal and ocular melanomas are also excluded, as these are approached differently for surgical excision
- •Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
- •Participants with known or suspected cancer with regional or distant metastasis are excluded from this clinical trial because this trial is aimed at evaluating the control of localized disease
- •The patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including a sentinel lymph node biopsy, of the index melanoma
- •Planned adjuvant radiotherapy to the primary melanoma site after excision
- •Participant is unwilling or unable to comply with study procedures
研究组 & 干预措施
Arm I (narrow margin excision)
Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm I (narrow margin excision)
Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
干预措施: Excision (Procedure)
Arm I (narrow margin excision)
Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Arm II (wide margin excision)
Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm II (wide margin excision)
Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
干预措施: Excision (Procedure)
Arm II (wide margin excision)
Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Local recurrence rate
时间窗: From randomization to end of year 3
Defined as average rate at which cancer returns to same location as the original tumor.
次要结局
- Regional (nodal) disease-free survival(From randomization to end of year 5)
- Local recurrence-free survival(From randomization to end of year 5)
- Melanoma-specific survival(From randomization to end of year 5)
- Postoperative pain(Up to 30 days after surgery)
- Surgical complication rate(Up to postoperative day 90)
- Frequency of complex reconstruction(Immediately after surgery)
- Defect size(Immediately after surgery)
- Number of operative/procedure days(Up to postoperative day 90)
- Quality of life(Up to postoperative day 90)
研究者
Noah Hornick, M.D.
Principal Investigator
OHSU Knight Cancer Institute