CN01: Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01067196
Collaborator
(none)
500
1
147.6
3.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.
Study Design
Study Type:
Observational
Actual Enrollment
:
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
Actual Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Dec 1, 2015
Actual Study Completion Date
:
May 21, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observation and quality of life Central Nervous System Tumors |
Outcome Measures
Primary Outcome Measures
- Measure late effects of proton therapy on pediatric patients with CNS tumors [5.4 years after treatment completion]
Secondary Outcome Measures
- Survival endpoints of local control, progression-free survival, and overall and cause-specific survival. [12 years after treatment completion]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Prior radiation therapy.
-
Evidence of metastases outside the central nervous system.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida Proton Therapy Institute | Jacksonville | Florida | United States | 32206 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Daniel J. Indelicato, MD, University of Florida Proton Therapy Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Bhat 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.
- 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.
- Huang 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.
- Sklar CA, Constine LS. Chronic neuroendocrinological sequelae of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1113-21. Review.
- Varni 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.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT01067196
Other Study ID Numbers:
- IRB201701741
- UFPTI 0903-CN01
First Posted:
Feb 11, 2010
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Keywords provided by University of Florida
Additional relevant MeSH terms: