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临床试验/NCT00064883
NCT00064883已完成不适用

The Natural History of Childhood Malignancies Treated With Radiation Therapy

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2003年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
1
主要终点
Changes in patient disease after radiation

研究概览

简要总结

This study will: 1) provide standard non-experimental radiation therapy to children who have a form of cancer or similar disease process that is of scientific interest, importance, or educational value; 2) determine the effects of radiation on childhood cancers; and 3) allow for the education of nurses, medical students, residents, clinical fellows, and physicians in the management and care of this specialized group of cancer patients. Patients in this study will not receive experimental therapy, but will be given standard medical care.

Patients eligible for this study include: 1) children with cancer or a precancer syndrome, such as aplastic anemia or other myelodysplastic syndrome, who are between 3 years and 21 years of age and whose disease will be treated or has been treated with radiation therapy in the NCI's Radiation Oncology Branch (ROB); 2) patients with cancer or a precancer syndrome who have disease manifestations of special interest to ROB investigators; and 3) patients with cancer or a precancer syndrome who offer an important educational benefit to radiation oncology trainees and staff.

Participants will undergo a medical history, physical examination, and blood tests, and radiation therapy. Before beginning treatment, medical information such as pathology reports, laboratory results, diagnosis and treatment history, scan results, and so forth, will be obtained from the patient's medical records. Additional procedures that may need to be done include scans, such as magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), lung function tests, arteriogram, or tumor biopsies.

Participants will then have a (simulation) treatment planning session for radiation therapy during which measurements are taken, CT images are taken, and markings are placed on the body to help determine the treatment area. The radiation will be delivered to the body by a machine called a linear accelerator, which produces x-rays. Radiation therapy is generally given once or twice a day 5 days a week. Each treatment takes about 10 minutes.

When the course of treatment is completed, patients return to the Radiation Oncology clinic for follow-up visits that include blood tests, a physical examination, and review of symptoms, if any. Visits are kept to a minimum, but continue for a prolonged period to watch for any late effects of treatment that may occur over a period of decades.

详细描述

BACKGROUND

-Children with cancer represent relatively rare disorders that are of unique scientific importance and educational value.

OBJECTIVE

-This protocol will allow follow-up of these patients for determination of the effects of radiation on overall survival, as well as relapse-free/ disease-free survival, local control, and the late sequelae of radiation therapy.

ELIGIBILITY

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes in patient disease after radiation

时间窗: at completion of treatment

Overall response

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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