ISRCTN99703266进行中（未招募）未知
Melanoma Margins Trial-II (MelMarT-II): 1 cm vs 2 cm wide surgical excision margins for AJCC stage II primary cutaneous melanoma
Melanoma and Skin Cancer Trials Ltd0 个研究点目标入组 2,998 人开始时间: 2021年7月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,998
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
- 性别
- All
入选标准
- •1. Patients must have a stage II primary invasive cutaneous melanoma with Breslow thickness >2 mm without ulceration, or >1 mm (with ulceration only) (pT2b-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 2 cm margin must be technically feasible around biopsy scar or primary melanoma
- •4. Staging sentinel node biopsy must be completed within 3 months (92 days) of the original diagnosis
- •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 principal investigator (PI)
- •8. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 1
- •9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
- •9.1. The patient has undergone potentially curative therapy for all prior malignancies
- •9.2. 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
- •9.3. 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
- •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 viscera
- •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 except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer
- •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
- •Pregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and sentinel node biopsy until the pregnancy has been completed, which is likely to exclude the patient due to violation of inclusion criterion 4. The researchers would advise careful counselling of the patient prior to enrolling the patient, which would include a discussion at the treating centre's multidisciplinary team meeting or tumour board. They would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.
研究者
相似试验
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)disease free survivalExcision margin10040795NL-OMON54102Melanoma and Skin Cancer Trials Limited, Melbourne Australia1,000
已完成
不适用
Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 MelanomaMalignant MelanomaNCT03034395University of Kansas Medical Center15
已完成
不适用
Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)MelanomaNCT02088762Insel Gruppe AG, University Hospital Bern325
招募中
不适用
The effect of 1 cm versus 2 cm resection margin and oncoplastic closure of breast parenchymal defect on immediate postoperative complications, cosmesis and patient satisfaction in women with early breast cancer (upto 4 cm): A 2 X 2 factorial design randomized controlled trialCTRI/2018/03/012288Human Resource Development Group CSIR174
已完成
3 期
PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)Neoplasm MetastasisMelanomaNCT00221702University Hospital, Bordeaux898