NCT01067196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

5.8 years

First QC Date

February 9, 2010

Last Update Submit

June 9, 2022

Conditions

Central Nervous System Tumors

Keywords

Proton RadiationCentral Nervous System (CNS) TumorsBrainSpineCancerRadiation Therapy (RT)

Outcome Measures

Primary Outcomes (1)

  • Measure late effects of proton therapy on pediatric patients with CNS tumors

    5.4 years after treatment completion

Secondary Outcomes (1)

  • Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.

    12 years after treatment completion

Study Arms (1)

Observation and quality of life

Central Nervous System Tumors

Eligibility Criteria

Age1 Day - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients treated at a radiation oncology clinic

You may qualify if:

  • 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.

You may not qualify if:

  • Prior radiation therapy.
  • Evidence of metastases outside the central nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (5)

  • 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.

    PMID: 8388548BACKGROUND

  • 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.

    PMID: 7713777BACKGROUND

  • 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.

    PMID: 11932914BACKGROUND

  • 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.

    PMID: 16110009BACKGROUND

  • 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.

    PMID: 11849779BACKGROUND

MeSH Terms

Conditions

Central Nervous System NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Officials

  • Daniel J. Indelicato, MD

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 11, 2010

Study Start

February 1, 2010

Primary Completion

December 1, 2015

Study Completion

May 21, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations

US(1)