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The Natural History of Childhood Malignancies Treated With Radiation Therapy
Sponsor study identifier
Secondary identifiers
observational
241
1 country
1
Study Start
July 28, 2003
Actual (reported)Primary Completion
July 25, 2019
Actual (reported)Study Completion
May 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 14, 2003
Actual (reported)July 15, 2003
Actual (reported)July 28, 2003
Actual (reported)July 25, 2019
Actual (reported)May 1, 2020
Actual (reported)Changes in patient disease after radiation
Overall response
at completion of treatment
Pediatric cancer patients referred to the ROB who have received or require radiation therapy
Children with cancer (or a precancer syndrome, such as aplastic anemia or other myelodysplastic syndrome) who require radiation
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Kevin A Camphausen, M.D.
National Cancer Institute (NCI)
241 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2003
First Posted
July 15, 2003
Study Start
July 28, 2003
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 25, 2019
Actual (reported)Study Completion
May 1, 2020
Actual (reported)Last Updated
May 4, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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