NCT02644993

Brief Summary

The study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. Based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. Risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.

Trial Health

55
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Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

10 years

First QC Date

December 28, 2015

Last Update Submit

October 12, 2016

Conditions

Pediatric Cancer Patients

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Questionnaire

    within 2 weeks before proton beam therapy

Secondary Outcomes (11)

  • Quality of Life Questionnaire baseline

    within 1 week before proton beam therapy completion

  • Quality of Life Questionnaire

    3-6 months after proton beam therapy

  • Quality of Life Questionnaire

    1 year after proton beam therapy

  • Quality of Life Questionnaire

    3 years after proton beam therapy

  • Quality of Life Questionnaire

    5 years after proton beam therapy

  • +6 more secondary outcomes

Study Arms (1)

Proton beam therapy

EXPERIMENTAL
Radiation: Proton therapy

Interventions

Proton therapyRADIATION
Proton beam therapy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • less than 18 years of age
  • patient who is planned to receive proton therapy at Samsung Medical Center
  • Informed consent

You may not qualify if:

  • Refuse to participate this cohort study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Do Hoon Lim, MD, PhD

    Proton therapy center, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Do Hoon Lim, MD, PhD

CONTACT

82-2-3410-2612dh8.lim@samsung.net

Jeong Il Yu, MD

CONTACT

ro.yuji651@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 1, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2025

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

KR(1)