Central Nervous System TumorsCN01NCT01067196
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
An observational study of Central Nervous System Tumors, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects. Read more about this study
- Who is it for?
- Ages 1 day to 20 years
- Conditions the study is for
- Central Nervous System Tumors
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 21 May 2022
- 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 1 day to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients treated at a radiation oncology clinic
Who may be able to join
- Estimated >5 cc of the brain tissue to receive >5 CGE radiation
- Patient must be less than 21 years of age at time of consent.
- Patients that require localized and craniospinal irradiation.
- Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group.
Who cannot join
- Prior radiation therapy.
- Evidence of metastases outside the central nervous system.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
Read the detailed description
Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.
- Conditions
- Central Nervous System Tumors
- Keywords
- Proton Radiation, Central Nervous System (CNS) Tumors, Brain, Spine, Cancer, Radiation Therapy (RT)
- Medical subject headings
- Central Nervous System Neoplasms, 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 |
|---|---|---|
| Observation and quality of life | Central Nervous System Tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure late effects of proton therapy on pediatric patients with CNS tumors
Measured: 5.4 years after treatment completion
Secondary outcomes (1)
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.
Measured: 12 years after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2015
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J. Indelicato, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067196
- Sponsor's protocol ID
- IRB201701741
- Other IDs
- UFPTI 0903-CN01
- Acronym
- CN01
- Status last verified
- Jun 2022
- First submitted
- 9 Feb 2010
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Duffner PK, Horowitz ME, Krischer JP, Friedman HS, Burger PC, Cohen ME, Sanford RA, Mulhern RK, James HE, Freeman CR, et al. Postoperative chemotherapy and delayed radiation in children less than three years of age with malignant brain tumors. N Engl J Med. 1993 Jun 17;328(24):1725-31. doi: 10.1056/NEJM199306173282401.
PubMed 8388548Sklar CA, Constine LS. Chronic neuroendocrinological sequelae of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1113-21. doi: 10.1016/0360-3016(94)00427-M.
PubMed 7713777Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Bhat SR, Goodwin TL, Burwinkle TM, Lansdale MF, Dahl GV, Huhn SL, Gibbs IC, Donaldson SS, Rosenblum RK, Varni JW, Fisher PG. Profile of daily life in children with brain tumors: an assessment of health-related quality of life. J Clin Oncol. 2005 Aug 20;23(24):5493-500. doi: 10.1200/JCO.2005.10.190.
PubMed 16110009Huang E, Teh BS, Strother DR, Davis QG, Chiu JK, Lu HH, Carpenter LS, Mai WY, Chintagumpala MM, South M, Grant WH 3rd, Butler EB, Woo SY. Intensity-modulated radiation therapy for pediatric medulloblastoma: early report on the reduction of ototoxicity. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):599-605. doi: 10.1016/s0360-3016(01)02641-4.
PubMed 11849779
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
- ClinicalTrials.gov ID
- NCT01067196
- Acronym / sponsor ID
- CN01 / IRB201701741
- Conditions
- Central Nervous System Tumors
- Keywords
- Proton Radiation, Central Nervous System (CNS) Tumors, Brain, Spine, Cancer, Radiation Therapy (RT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 11 Feb 2010 (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.
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
Detailed description
Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation and quality of life | – | –Central Nervous System Tumors |
Who may qualify
- Ages
- 1 day to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients treated at a radiation oncology clinic
Key inclusion criteria (4 listed)
- Estimated >5 cc of the brain tissue to receive >5 CGE radiation
- Patient must be less than 21 years of age at time of consent.
- Patients that require localized and craniospinal irradiation.
- Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group.
Key exclusion criteria (2 listed)
- Prior radiation therapy.
- Evidence of metastases outside the central nervous system.
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
Measure late effects of proton therapy on pediatric patients with CNS tumors
Time frame: 5.4 years after treatment completion
1 secondary outcome
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.
Time frame: 12 years after treatment completion
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 10 Jun 2022.
- Background: PubMed 8388548Duffner PK, Horowitz ME, Krischer JP, Friedman HS, Burger PC, Cohen ME, Sanford RA, Mulhern RK, James HE, Freeman CR, et al. Postoperative chemotherapy and delayed radiation in children less than three years of age with malignant brain tumors. N Engl J Med. 1993 Jun 17;328(24):1725-31. doi: 10.1056/NEJM199306173282401.
- Background: PubMed 7713777Sklar CA, Constine LS. Chronic neuroendocrinological sequelae of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1113-21. doi: 10.1016/0360-3016(94)00427-M.
- Background: PubMed 11932914Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
- Background: PubMed 16110009Bhat SR, Goodwin TL, Burwinkle TM, Lansdale MF, Dahl GV, Huhn SL, Gibbs IC, Donaldson SS, Rosenblum RK, Varni JW, Fisher PG. Profile of daily life in children with brain tumors: an assessment of health-related quality of life. J Clin Oncol. 2005 Aug 20;23(24):5493-500. doi: 10.1200/JCO.2005.10.190.
- Background: PubMed 11849779Huang E, Teh BS, Strother DR, Davis QG, Chiu JK, Lu HH, Carpenter LS, Mai WY, Chintagumpala MM, South M, Grant WH 3rd, Butler EB, Woo SY. Intensity-modulated radiation therapy for pediatric medulloblastoma: early report on the reduction of ototoxicity. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):599-605. doi: 10.1016/s0360-3016(01)02641-4.
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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.
Daniel J. Indelicato, MD principal investigator
University of Florida
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 Central Nervous System Tumors, run by University of Florida 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 4 inclusion and 2 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 10 Jun 2022. 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?
Measure late effects of proton therapy on pediatric patients with CNS tumors (time frame: 5.4 years after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067196, which also lists 5 linked publications.
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 10 Jun 2022.