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Breast-Sparing Proton Therapy for Hodgkin's Disease (Breast Sparing)

2015年2月3日 更新者:Indiana University

Breast-Sparing Proton Therapy for Hodgkin's Disease in Young Females Demonstrated By Positron Emission Tomograpy (PET) Scanning: A Pilot Study

The purpose of this study is to drastically reduce unnecessary breast dose in young females with Hodgkin's Disease who require radiation therapy.

研究概览

地位

终止

条件

干预/治疗

详细说明

According to the National Cancer Institute's Surveillance, Epidemiology, and End Results Program, there will be an estimated 8,490 new cases of Hodgkin's Lymphoma (HL) in the United States in 2010, with an estimated 1,320 deaths (Jemal, Siegel et al.). The unadjusted rates of 5 year overall survival are approximately 95%, and remain among the highest of all childhood and adult malignancies. With many children and young adults surviving into advanced age, the impetus has been to develop less toxic yet equally effective treatments. One of the main approaches taken over the last 25 years to minimize long-term treatment toxicity has been to limit the amount and volume of radiation received by patients. This pilot study continues along those lines, attempting to further refine the delivery of radiation therapy (RT) in order to avoid one of the most notorious long-term side-effects: secondary breast cancer.

Multiple studies investigating late toxicity in long-term survivors of pediatric Hodgkin's Lymphoma have shown the risk of breast cancer in young females receiving mediastinal radiation to be 50 times greater than their age-matched counterparts. The Late Effects Study Group, with a median follow-up of 17 years, reported a breast cancer incidence of 16% with a standardized incidence ratio of 55.5 (Bhatia, Yasui et al. 2003). Through utilization of breast-sparing proton therapy, we hope to provide young female patients with the benefits of radiation therapy while decreasing their risk of secondary breast cancer, thus increasing the therapeutic ratio.

In a prior computer-based, in-silico, dose planning study, utilizing the most basic beam orientation (a single PA beam), we showed that dose to breast tissue was reduced by a minimum of at least 80% with proton treatment compared to standard AP-PA photon treatment (in publication). Furthermore, dose to clinical target volume was maintained, and dose to other normal structures was statistically no worse. We now aim to validate these findings by verifying the beam range, in-vivo, via post-treatment combined Positron Emission Tomography-Computer Tomography (PET-CT) imaging in young females undergoing supra-diaphragmatic radiotherapy for Hodgkin's Disease.

研究类型

介入性

注册 (实际的)

3

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Indiana
      • Bloomington、Indiana、美国、47408
        • Indiana University Health Proton Therapy Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 30年 (孩子、成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female sex
  • Age >/= 10 years old and < 30 years old
  • Pathologically confirmed classical Hodgkin's Lymphoma
  • At least one site of disease located above the diaphragm
  • Signed study-specific consent prior to initiation of therapy
  • Women of child-bearing potential must have a negative pregnancy blood test within 7 days of starting protocol therapy.

Exclusion Criteria:

  • Previous radiation therapy to any part of the body.
  • Parenchymal lung involvement at initial presentation or any patient that may need whole lung irradiation as per institutional guidelines.
  • Lymphocyte predominant histology not eligible.
  • Significant infection or other coexistent medical condition that would preclude protocol therapy such as:

    • History of HIV/AIDS
    • History of collagen Vascular Disease
    • Symptomatic congestive heart failure
    • Unstable angina pectoris or myocardial infarction within 6 months
    • Uncontrolled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg on 2 consecutive measurements separated by 1 week).
    • History of uncontrolled diabetes
    • Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Radiation Treatment using Protons
14 -24 Radiation Treatments (typically 1.5 - 1.8 cobalt-Gray equivalent per fraction for 14-24 treatments).
14-24 Radiation treatments using Protons
其他名称:
  • Breast sparing using proton beams

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Comparative DVH data for delivered proton plan and accompanying photon plan for target volume and normal tissues.
大体时间:12 months

Dose-volume histogram data from both the delivered proton plan and the accompanying photon plan for target volumes and normal tissues, including:

• Breast, heart, lung, thyroid, parotid glands , esophagus, spinal cord, *liver, *kidneys,

12 months

次要结果测量

结果测量
措施说明
大体时间
Treatment toxicity and disease control of proton therapy for the treatment of pediatric Hodgkin's Lymphoma.
大体时间:3 - 60 Months
  1. Acute toxicity as per CTCAE v4.0
  2. Local, regional, and distal control of the disease at 3 years
3 - 60 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jeffery Buchsbuam, MD、Indiana University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年9月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2012年4月19日

首先提交符合 QC 标准的

2014年2月21日

首次发布 (估计)

2014年2月25日

研究记录更新

最后更新发布 (估计)

2015年2月4日

上次提交的符合 QC 标准的更新

2015年2月3日

最后验证

2015年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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