NL-OMON54102招募中3 期
Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II) - MelMarT-II
Melanoma and Skin Cancer Trials Limited, Melbourne Australia0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients must have a stage II primary invasive cutaneous melanoma with
- •Breslow thickness 2.01mm to 4mm or >4mm with or without ulceration (pT3a-pT4b,
- •AJCC 8th edition) as determined by
- •diagnostic biopsy (narrow excision, incision or punch biopsy) and
- •subsequent histopathological analysis.
- •2. Must have a primary melanoma that is cutaneous (including head, neck, trunk,
- •extremity, scalp, palm or sole).
- •3. An uninterrupted 2cm margin must be technically feasible around biopsy scar
- •or primary melanoma.
- •4. Surgical intervention (which refers to SLNB and WLE as these are both to be
- •done on the same day), must be completed within 120 days of the original
- •5. Patients must be 18 years or older at time of consent.
- •6. Patient must be able to give informed consent and comply with the treatment
- •protocol and follow-up plan.
- •7. Life expectancy of at least 5 years from the time of diagnosis, not
- •considering the melanoma in question, as determined by the PI.
- •8. Patients must have an ECOG performance score between 0 and 1 at screening.
- •9. A survivor of prior cancer is eligible provided that ALL of the following
- •criteria are met and documented:
- •o The patient has undergone potentially curative therapy for all prior
- •malignancies,
- •o There has been no evidence of recurrence of any prior malignancies
- •for at least FIVE years (with the exception if successfully treated
- •uterine/cervical or non-melanoma skin cancers
- •(SCCs/BCCs with no evidence of recurrence), and
- •o The patient is deemed by their treating physician to be at low risk
- •of recurrence from previous malignancies.
排除标准
- •1. Uncertain diagnosis of melanoma i.e. so-called *melanocytic lesion of
- •unknown malignant potential*.
- •2. Patient has already undergone wide local excision at the site of the primary
- •index lesion.
- •3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy
- •of the primary index lesion.
- •4. Desmoplastic or neurotropic melanoma: with any patient where pathology
- •determines melanoma as PURE desmoplastic (as per WHO definition of >90%
- •desmoplasia),
- •they are not eligible for this study. However other melanomas with less
- •than 90% desmoplasia or mixed subtypes are eligible unless there is
- •neurotropism present (peri
- •neural invasion). Neurotropism in any type of melanoma is an exclusion.
- •Peri-neural invasion does not include entrapment of nerves within the main
- •primary tumour
- •5. Microsatellitosis as per AJCC 8th edition definition
- •6. Subungual melanoma
- •7. 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.
- •8. History of previous or concurrent (i.e., second primary) invasive melanoma.
- •9. Melanoma located distal to the metacarpophalangeal joint; on the tip of the
- •nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes
- •or internal
- •10. Physical, clinical, radiographic or pathologic evidence of satellite,
- •in-transit, regional, or distant metastatic melanoma.
- •11. 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.
- •12. Any additional solid tumour or hematologic malignancy during the past 5
- •years (with exception of non-melanoma skin cancers (T1 skin lesions of squamous
- •carcinoma (SCCs), basal cell carcinoma (BCC*s)), or uterine/cervical
- •13. Melanoma-related operative procedures not corresponding to criteria
- •described in the protocol.
- •14. 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.
- •15. History of organ transplantation.
- •16. Oral or parenteral immunosuppressive agents (not topical or inhaled
- •steroids) at enrolment or within 6 months prior to enrolment.
研究者
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