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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Do Hoon Lim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02644993
First received: December 28, 2015
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Pediatric Cancer Patients
Radiation: Proton therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Quality of Life Questionnaire [ Time Frame: within 2 weeks before proton beam therapy ]

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

Estimated Enrollment: 400
Study Start Date: November 2015
Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton beam therapy Radiation: Proton therapy

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02644993

Contacts
Contact: Do Hoon Lim, MD, PhD 82-2-3410-2612 dh8.lim@samsung.net
Contact: Jeong Il Yu, MD ro.yuji651@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Do Hoon Lim, MD, PhD    82-2-3410-2612    dh8.lim@samsung.net   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Do Hoon Lim, MD, PhD Proton therapy center, Samsung Medical Center
  More Information

Responsible Party: Do Hoon Lim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02644993     History of Changes
Other Study ID Numbers: 2015-10-111 
Study First Received: December 28, 2015
Last Updated: October 12, 2016

ClinicalTrials.gov processed this record on February 20, 2017