Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck

Central Nervous System Tumors Clinical Trial

— CN01  

Official title:

A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067196
• Other study ID #: IRB201701741
• Secondary ID: UFPTI 0903-CN01
• Status: Completed
• Start date: February 2010
• Est. completion date: May 21, 2022

Study information

• Verified date: June 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 21, 2022
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Central Nervous System Neoplasms
• Central Nervous System Tumors
• Neoplasms
• Nervous System Neoplasms

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Sklar CA, Constine LS. Chronic neuroendocrinological sequelae of radiation therapy. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1113-21. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure late effects of proton therapy on pediatric patients with CNS tumors		5.4 years after treatment completion
Secondary	Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.		12 years after treatment completion