ACTRN12611000212954招募中未知
A randomised trial of postoperative radiation therapy following wide excision of neurotropic melanoma of the head and neck to compare rate and timing of local relapse
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 100 人开始时间: 2011年2月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Aged 18 years or older
- •- Has provided written informed consent for participation in this trial
- •- Histologically confirmed neurotropic primary melanoma
- •- Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary)
- •- Complete macroscopic resection of all known disease with negative microscopic margins
- •- No previous surgery for melanoma (other than complete macroscopic resection as stated above)
- •- No evidence of in-transit, nodal or distant metastases as determined by clinical examination, and any form of imaging
- •- ECOG performance status score of 2 or less
- •- Life expectancy greater than 6 months
- •- Patients capable of childbearing are using adequate contraception
- •- Available for follow up
排除标准
- •- Women who are pregnant or lactating
- •- Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition
- •- Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour
- •- Inability to localise surgical bed on any form of imaging and/or surgical margins (cm) not known
- •- Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous SCC or basal cell carcinoma, which is not within or overlapping the tumour bed
- •- High risk for poor compliance with therapy or follow-up as assessed by investigator
- •- Patients with prior cancers, except: those diagnosed greater than or equal to 5 years ago with no evidence of disease relapse and clinical expectation of relapse of less than 5%; prior successfully treated Level 1 cutaneous melanomas greater than or equal to 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix
- •- Albinism
- •- Participation in other clinical trials with the same primary endpoint
研究者
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