CancerNCT00064883
Radiation Therapy and the Natural History of Childhood Cancers
An observational study of Cancer and Childhood Malignancy, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Cancer, Childhood Malignancy
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2003to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cancer (or a precancer syndrome, such as aplastic anemia or other myelodysplastic syndrome) who require radiation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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 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.
Read more
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.
Read the 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
- Keywords
- Radiation Therapy, Children, Cancer, Late Effects, Natural History, Radiation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Pediatric cancer patients referred to the ROB who have received or require radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient disease after radiation
Overall response
Measured: at completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study start28 Jul 2003
- Primary completion25 Jul 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064883
- Sponsor's protocol ID
- 030241
- Other IDs
- 03-C-0241
- Status last verified
- May 2020
- First submitted
- 14 Jul 2003
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Childhood Malignancies Treated With Radiation Therapy
- ClinicalTrials.gov ID
- NCT00064883
- Acronym / sponsor ID
- 030241
- Conditions
- Cancer, Childhood Malignancy
- Keywords
- Radiation Therapy, Children, Cancer, Late Effects, Natural History, Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 28 Jul 2003 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 15 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Pediatric cancer patients referred to the ROB who have received or require radiation therapy |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cancer (or a precancer syndrome, such as aplastic anemia or other myelodysplastic syndrome) who require radiation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in patient disease after radiation
Time frame: at completion of treatment
Overall response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin A Camphausen, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Childhood Malignancy, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient disease after radiation (time frame: at completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.