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临床试验/NCT02039895
NCT02039895Unknown不适用

Helical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma

Far Eastern Memorial Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Number of Participants with Serious and Non-Serious Adverse Events

研究概览

简要总结

Radiation therapy, Total skin electron beam therapy (TSEBT), achieves a high response rate and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region. One the most widely used TSEBT techniques consists of six dual fields initially developed at Stanford University. However, deviations occur from the prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas such as the perineum and eyelid.

Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length of up to 160 cm, continuously in a helical pattern without the need for field junction. Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSEBT technique to increase dose delivery and decrease toxicities possibly. Recently, we published the possibility of helical irradiation of the total skin (HITS) by physical proving and showed the clinical results of HITS successfully for a woman with T cell lymphoma failure by chemotherapy, topic UV irradiation and local radiotherapy (RT) to overcome the surface dose inhomogeneity by conventional RT.

Here, investigators will enroll the stage I-IV cutaneous T-cell lymphoma (CTCL) of International Society Cutaneous Lymphomas (ISCL)/U.S. Cutaneous Lymphoma Consortium (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are candidates for TSEBT by recommendation of National Comprehensive Cancer Network Guidelines (Version 4.2011, Mycosis fungoid/Sezary syndrome) or who are refractory or not feasible to the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy, and Accutane® (Isotretinoin) or chemotherapy to receive HITS to replace TSEBT. Additionally, we will compare the advantages and disadvantages between the plan of HT and conventional RT for TSEBT.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The stage I-IV cutaneous T-cell lymphoma (CTCL) of International Society Cutaneous Lymphomas (ISCL) and U.S. Cutaneous Lymphoma Consortium (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are candidates for TSEB by recommendation of National Comprehensive Cancer Network Guidelines (Version 4.2011, Mycosis fungoid/Sezary syndrome)
  • Patients who are refractory or not feasible to the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy, and Isotretinoin or chemotherapy.
  • Eligibility criteria included the following: Karnofsky status 70% or greater; creatinine clearance greater than 50 mL/min; cardiac left ventricular ejection fraction 50% or greater; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the upper limits of institutional normal; adequate pulmonary function as shown by a forced expiratory volume of greater than 60%; and peripheral neuropathy grade 1 or lower. Patients were preassessed for their ability to lie supine for approximately 1 hour.
  • They had to be previously untreated TSEBT. Prior local radiation was permitted.
  • All patients voluntarily signed an informed consent form approved by the Institutional Review Board.

排除标准

  • Patient were prior treated by TSEBT for CTCL, another type of cancer, abnormal cardiac function (systolic ejection fraction < 50 percent or an abnormal stress test), chronic respiratory disease (vital capacity or carbon monoxide diffusion, < 50 percent of normal), abnormal liver function (serum bilirubin, > 2.0 mg per deciliter [>35 micromol per liter]; or serum aminotransferase values more than four times the normal value), and psychiatric disease.
  • Females who are pregnant/lactating or planning to be pregnant.
  • Patients with other systemic diseases that required long-term (≥ 2 weeks) usage of glucocorticosteroid or immunosuppressant agent(s) within 4 weeks prior to the initiation of study treatment.
  • Child or handicap are excluded

研究组 & 干预措施

HITS for CTCL

Experimental

Cutaneous T-cell lymphoma treats by helical irradiation of the total skin (HITS) using helical tomotherapy

干预措施: HITS (Radiation)

结局指标

主要结局

Number of Participants with Serious and Non-Serious Adverse Events

时间窗: 3 months

participants will be followed from the duration of RT to RT finish 1 month, an expected average of 3 ms

次要结局

  • Time to Disease Progression(Up to 24 ms)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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