Radiation Therapy and the Natural History of Childhood Cancers
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|ClinicalTrials.gov Identifier: NCT00064883|
Recruitment Status : Completed
First Posted : July 15, 2003
Last Update Posted : May 4, 2020
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.
|Condition or disease|
|Cancer Childhood Malignancy|
-Children with cancer represent relatively rare disorders that are of unique scientific importance and educational value.
-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.
-Children with cancer and who require radiation are referred to the Radiation Oncology Branch primarily from Children's National Medical Center in Washington, D.C. and from other Branches of the NCI/NIH.
-This protocol is designed to provide the radiation component of therapy in children with cancer that have diseases that are of unique scientific interests, importance, and/or educational value.
|Study Type :||Observational|
|Actual Enrollment :||241 participants|
|Official Title:||The Natural History of Childhood Malignancies Treated With Radiation Therapy|
|Actual Study Start Date :||July 28, 2003|
|Actual Primary Completion Date :||July 25, 2019|
|Actual Study Completion Date :||May 1, 2020|
Pediatric cancer patients referred to the ROB who have received or require radiation therapy
- Changes in patient disease after radiation [ Time Frame: at completion of treatment ]Overall response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064883
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Kevin A Camphausen, M.D.||National Cancer Institute (NCI)|