Clinical trial NCT01067196: Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
Official title: A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Tumors
Keywords: Proton Radiation
Central Nervous System (CNS) Tumors
Brain
Spine
Cancer
Radiation Therapy (RT)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at a radiation oncology clinic

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.

Detailed description: Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure late effects of proton therapy on pediatric patients with CNS tumors
timeFrame: 5.4 years after treatment completion
Secondary outcomes:
measure: Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.
timeFrame: 12 years after treatment completion
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Daniel J. Indelicato, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sklar 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.
citation: 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. doi: 10.1002/cncr.10428.
citation: 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. doi: 10.1200/JCO.2005.10.190.
citation: 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. doi: 10.1016/s0360-3016(01)02641-4.