A Phase III, Multi-centre, Multi-national Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 37
- 主要终点
- Local Melanoma Recurrence (Melanoma Specific Survival)
研究概览
简要总结
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients
详细描述
This study will determine whether there is a difference in local recurrence rates and melanoma survival rates for patients treated with either a 1cm excision margin or 2cm margin for both intermediate & high risk melanomas. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be halved. If the study shows no risk of the tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.
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
- •Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
- •Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.
- •Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
- •An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
- •Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.
- •Patients must be 18 years or older at time of consent.
- •Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
- •Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
- •Patients must have an ECOG performance score between 0 and
- •A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
- •The patient has undergone potentially curative therapy for all prior malignancies,
- •There has been no evidence of recurrence of any prior malignancies for at least FIVE years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
- •The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.
排除标准
- •Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
- •Patient has already undergone wide local excision at the site of the primary index lesion.
- •Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
- •Desmoplastic or neurotropic melanoma.
- •Microsatellitosis as per AJCC 2009 definition
- •Subungual melanoma
- •Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
- •History of previous or concurrent (i.e., second primary) invasive melanoma.
- •Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
- •Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
- •Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma.
- •Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.
- •Melanoma-related operative procedures not corresponding to criteria described in the protocol.
- •Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.
- •History of organ transplantation.
- •Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.
结局指标
主要结局
Local Melanoma Recurrence (Melanoma Specific Survival)
时间窗: 0-120 months
Time from randomisation to clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes.
次要结局
- Recurrence-Free Survival(0-120 months)
- Overall Survival(0-120 Months)
- Adverse events(Within 1 year)
- QoL and neuropathic pain assessments Neuropathic Pain (PainDetect)(Baseline, 3, 6 12, 24 & 60 months.)
- Health System Resource Use(Baseline, 3, 6, 12, 24 and 60 months)
- Surgery related adverse events(Up to 30 days from randomisation)