Pediatric Cancer PatientsNCT02644993
Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy
A study testing Proton therapy in people with Pediatric Cancer Patients, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Cancer Patients
- What is being tested?
- Proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- less than 18 years of age
- patient who is planned to receive proton therapy at Samsung Medical Center
- Informed consent
Who cannot join
- Refuse to participate this cohort study
Trial locations and contacts
1 site in 1 country.
Jeong Il Yu, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Do Hoon Lim, MD, PhD, 82-2-3410-2612, dh8.lim@samsung.net
About this study
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.
- Conditions
- Pediatric Cancer Patients
- Being tested
- Proton therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Proton beam therapy | Experimental | Not described Receives: Radiation: Proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Measured: within 2 weeks before proton beam therapy
Secondary outcomes (11)
Quality of Life Questionnaire baseline
Measured: within 1 week before proton beam therapy completion
Quality of Life Questionnaire
Measured: 3-6 months after proton beam therapy
Quality of Life Questionnaire
Measured: 1 year after proton beam therapy
Quality of Life Questionnaire
Measured: 3 years after proton beam therapy
Quality of Life Questionnaire
Measured: 5 years after proton beam therapy
Quality of Life Questionnaire
Measured: 10 years after proton beam therapy
Adverse event
Measured: 3-6 months after proton beam therapy
Adverse event
Measured: 1 year after proton beam therapy
Adverse event
Measured: 3 years after proton beam therapy
Adverse event
Measured: 5 years after proton beam therapy
Adverse event
Measured: 10 years after proton beam therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Hoon Lim, Samsung Medical Center
- Investigators
- Do Hoon Lim, MD, PhD, Principal investigator, Proton therapy center, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644993
- Sponsor's protocol ID
- 2015-10-111
- Status last verified
- Oct 2016
- First submitted
- 28 Dec 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy
- ClinicalTrials.gov ID
- NCT02644993
- Acronym / sponsor ID
- 2015-10-111
- Conditions
- Pediatric Cancer Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2025 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton beam therapy | Experimental | Radiation: Proton therapy |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- less than 18 years of age
- patient who is planned to receive proton therapy at Samsung Medical Center
- Informed consent
Key exclusion criteria (1 listed)
- Refuse to participate this cohort study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton therapy | Radiation | Proton beam therapy |
Primary outcome
Quality of Life Questionnaire
Time frame: within 2 weeks before proton beam therapy
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Il Yu, MD contact
Do Hoon Lim, MD, PhD principal investigator
Proton therapy center, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton therapy in people with Pediatric Cancer Patients, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Do Hoon Lim, MD, PhD (82-2-3410-2612, dh8.lim@samsung.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: within 2 weeks before proton beam therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.