Radiation Therapy and the Natural History of Childhood Cancers

NCT ID: NCT00064883

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-07-28
• Study Completion Date: 2020-05-01

Brief 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.

Conditions

Cancer; Childhood Malignancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Pediatric cancer patients referred to the ROB who have received or require radiation therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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 3 - 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 3- 21 years, whose cancer (or precancer syndrome) have already been treated with radiation therapy in the Radiation Oncology Branch, NCI.

Exclusion Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin A Camphausen, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2003-C-0241.html

NIH Clinical Center Detailed Web Page

Other Identifiers

03-C-0241

Identifier Type: -

Identifier Source: secondary_id

030241

Identifier Type: -

Identifier Source: org_study_id

NCT00068536

Identifier Type: -

Identifier Source: nct_alias