Outcomes Study of Late Effects After Proton RT for Pediat... | NCT01067196

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

NCT01067196

Sponsor

University of Florida

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Central Nervous System Tumors

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UFPTI 0903-CN01	Other Identifier	University of Florida Project #

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010Actual

Primary Completion Date

Dec 2015Actual

Completion Date

May 21, 2022Actual

First Submitted Date

Feb 9, 2010

First Submission Date that Met QC Criteria

Feb 9, 2010

First Posted Date

Feb 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2022

Last Update Posted Date

Jun 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Label	Type	Description	Intervention Names
Observation and quality of life		Central Nervous System Tumors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure late effects of proton therapy on pediatric patients with CNS tumors		5.4 years after treatment completion

Secondary Outcomes

Measure	Description	Time Frame
Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.		12 years after treatment completion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Patients treated at a radiation oncology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel J. Indelicato, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida Proton Therapy Institute		Jacksonville	Florida	32206	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8388548	Background	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.
7713777	Background

ID	Term
D016543	Central Nervous System Neoplasms
D009369	Neoplasms

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009422	Nervous System Diseases