Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy

October 12, 2016 updated by: Do Hoon Lim, Samsung Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refuse to participate this cohort study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton beam therapy
Radiation: Proton therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire
Time Frame: within 2 weeks before proton beam therapy
within 2 weeks before proton beam therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire baseline
Time Frame: within 1 week before proton beam therapy completion
within 1 week before proton beam therapy completion
Quality of Life Questionnaire
Time Frame: 3-6 months after proton beam therapy
3-6 months after proton beam therapy
Quality of Life Questionnaire
Time Frame: 1 year after proton beam therapy
1 year after proton beam therapy
Quality of Life Questionnaire
Time Frame: 3 years after proton beam therapy
3 years after proton beam therapy
Quality of Life Questionnaire
Time Frame: 5 years after proton beam therapy
5 years after proton beam therapy
Quality of Life Questionnaire
Time Frame: 10 years after proton beam therapy
10 years after proton beam therapy
Adverse event
Time Frame: 3-6 months after proton beam therapy
3-6 months after proton beam therapy
Adverse event
Time Frame: 1 year after proton beam therapy
1 year after proton beam therapy
Adverse event
Time Frame: 3 years after proton beam therapy
3 years after proton beam therapy
Adverse event
Time Frame: 5 years after proton beam therapy
5 years after proton beam therapy
Adverse event
Time Frame: 10 years after proton beam therapy
10 years after proton beam therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Do Hoon Lim, MD, PhD, Proton therapy center, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-10-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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