Radiation Therapy and the Natural History of Childhood Cancers
|First Received Date ICMJE||July 14, 2003|
|Last Updated Date||April 12, 2013|
|Start Date ICMJE||July 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00064883 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Radiation Therapy and the Natural History of Childhood Cancers|
|Official Title ICMJE||The Natural History of Childhood Malignancies Treated With Radiation Therapy|
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 6 months 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.
-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 ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients who are evaluated by the Radiation Oncology Branch and are:
Children with cancer (or a precancer syndromes, such as aplastic anemia or other myelodysplastic syndromes), between the age(s) of 6 months - 21 years, whose cancer (or precancer syndrome) will be treated with radiation therapy in the Radiation Oncology Branch, NCI.
Patients with cancer (or a precancer syndromes, such as aplastic anemia or other myelodysplastic syndromes), who present with disease manifestations of special interest to Radiation Oncology Branch investigators, because they are likely to shed led light on the natural history, pathogenesis, radiation response, and late effects of disease process.
Patients with cancer (or precancer syndromes, such as aplastic anemia or other myelodysplastic syndromes) who offer an important educational benefit to trainees in radiation oncology and staff.
Patient must have a primary physician in the community who specializes in pediatrics and/or oncology and is willing to collaborate with the ROB staff in the clinical management of the patient
If indicated, availability of a parent or legal guardian to give informed consent
Children with cancer (or a precancer syndrome, such as aplastic anemia or other myelodysplastic syndrome), between the age(s) of 6 months - 21 years, whose cancer (or precancer syndrome) have already been treated with radiation therapy in the Radiation Oncology Branch, NCI.
Patients, and/or guardians who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment and follow-up requirements.
Patients who are enrolled on a clinical trial (e.g. COG or CNMC) in which one of the research objectives is to study the radiation treatment.
Patients who are pregnant and are to receive radiation treatment on this protocol.
|Ages||up to 21 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00064883|
|Other Study ID Numbers ICMJE||030241, 03-C-0241|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP