Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064883
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2003-07-14
Brief Title:
Radiation Therapy and the Natural History of Childhood Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Natural History of Childhood Malignancies Treated With Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NCIs 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 patients 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
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 NCIs 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 patients 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 Childrens National Medical Center in Washington DC and from other Branches of the NCINIH
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 andor educational value
-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 Childrens National Medical Center in Washington DC and from other Branches of the NCINIH
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 andor educational value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0241 | None | None | None |