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

Pediatric Cancer Patients Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02644993
• Other study ID #: 2015-10-111
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2015
• Last updated: October 12, 2016
• Start date: November 2015

Study information

• Verified date: October 2016
• Source: Samsung Medical Center
• Contact: Do Hoon Lim, MD, PhD
• Phone: 82-2-3410-2612
• Email: dh8.lim[@]samsung.net
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Cancer Patients

Intervention

Radiation:
• Proton therapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Questionnaire		within 2 weeks before proton beam therapy	No
Secondary	Quality of Life Questionnaire baseline		within 1 week before proton beam therapy completion	No
Secondary	Quality of Life Questionnaire		3-6 months after proton beam therapy	No
Secondary	Quality of Life Questionnaire		1 year after proton beam therapy	No
Secondary	Quality of Life Questionnaire		3 years after proton beam therapy	No
Secondary	Quality of Life Questionnaire		5 years after proton beam therapy	No
Secondary	Quality of Life Questionnaire		10 years after proton beam therapy	No
Secondary	Adverse event		3-6 months after proton beam therapy	No
Secondary	Adverse event		1 year after proton beam therapy	No
Secondary	Adverse event		3 years after proton beam therapy	No
Secondary	Adverse event		5 years after proton beam therapy	No
Secondary	Adverse event		10 years after proton beam therapy	No