Radiation Therapy and the Natural History of Childhood Cancers
Condition: Cancer; Childhood Malignancy
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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

      -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.

      DESIGN

      -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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with cancer (or a precancer syndrome, such as aplastic anemia or other
        myelodysplastic syndrome) who require radiation
      
Keywords: Radiation Therapy; Children; Cancer; Late Effects; Natural History; Radiation