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

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ClinicalTrials.gov Identifier: NCT02644993
Recruitment Status : Recruiting
First Posted : January 1, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Do Hoon Lim, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Patients Radiation: Proton therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : November 2025

Arm Intervention/treatment
Experimental: Proton beam therapy Radiation: Proton therapy



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

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Do Hoon Lim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02644993     History of Changes
Other Study ID Numbers: 2015-10-111
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016