Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 39
- 主要终点
- 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
研究概览
简要总结
This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Assess the recurrence rates in patients with desmoplastic melanoma (DM) >= 1 mm deep treated with adjuvant radiotherapy after surgical resection.
II. Assess recurrence rates in patients with locally recurrent DM treated with adjuvant radiotherapy after surgical resection.
SECONDARY OBJECTIVES:
I. Evaluate the impact of adjuvant radiation therapy after surgical resection on disease free and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- •Pathologically proven DM >= 1 mm in depth or locally recurrent DM; recurrent tumor is defined as a tumor found =< 2 cm from the previous excision or within the surgical bed (which includes the extent of previous skin flaps)
- •DM resected with pathologically negative margins; acceptable surgery includes standard wide local excision and Moh's surgery
- •Tumors on the trunk proximal extremities need to have a >= 2 cm negative margin; tumors located on the head and neck and distal extremities will have an attempt at 2 cm negative margins but due to location and subsequent concern regarding cosmesis a margin < 2 cm will be acceptable if margin is negative
- •Margins from tumors resected using the Moh's technique will be accepted if negative and best approximation of tumor width will be made
- •Radiation therapy (RT) is to begin =< 8 weeks after definitive surgical resection
- •Adjuvant systemic therapy (immunotherapy or chemotherapy) must be postponed until irradiation is completed
排除标准
- •Previous irradiation to the same site
- •Non-healing surgical wound
- •Active infection at the surgical site
- •Evidence of metastatic disease; local nodal disease is still eligible for the trial
- •Life expectancy < 1 year
- •Melanoma with focally desmoplastic features, in which the desmoplastic melanoma is not the predominant histologic pattern of the tumor, will be excluded; non-desmoplastic neurotropic melanoma and non-desmoplastic spindle cell melanoma are also excluded
- •Previous malignancy < 5 years excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ (with the exception of patients who have stage I breast cancer who were adequately treated with adjuvant therapy and are currently disease free, and patients with stage I or II prostate cancer treated with prostatectomy or radiotherapy and are biochemically free of disease [for radical retropubic prostatectomy (RRP) prostate-specific antigen (PSA) < 0.3 and for radiotherapy PSA < 2.0 above the post treatment nadir])
- •Any of the following:
- •Pregnant women
- •Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, abstinence, etc.)
研究组 & 干预措施
Treatment (adjuvant radiation therapy)
Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly over approximately 2.5 weeks for a total of 5 fractions in the absence of disease progression or unacceptable toxicity.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
时间窗: Within 2 years after treatment
The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.
次要结局
- Incidence of Regional and Systemic Metastases(Up to 5 years)
- Failure Time(Time from randomization to death due to any cause or disease progression (up to 5 years))
- Toxicity(Up to 5 years)
- Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory(Baseline to up to 3 months)
- Survival Time(up to 5 years)