Osteosarcoma in ChildrenNCT03139318
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
A study testing GRID radiotherapy in people with Osteosarcoma in Children and Radiation Toxicity, run by University of Arkansas at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Osteosarcoma in Children, Radiation Toxicity
- What is being tested?
- GRID radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
- 5-21 years of age.
- Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
- Informed consent is obtained
Who cannot join
- Females with a positive urine pregnancy test.
- Unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.
Read the detailed description
Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.
- Conditions
- Osteosarcoma in Children, Radiation Toxicity
- Being tested
- GRID radiotherapy
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRID radiotherapyRadiation
Patients will be treated with GRID radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| GRID Radiotherapy | Experimental | Patients will be treated with GRID Radiotherapy Receives: Radiation: GRID radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Toxicities Associated With GRID Radiotherapy
The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.
Measured: An average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start25 Jul 2017
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Why it stopped: Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteosarcoma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Harrell, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139318
- Sponsor's protocol ID
- 205993
- Status last verified
- Jun 2022
- First submitted
- 25 Apr 2017
- Last updated
- 20 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
- ClinicalTrials.gov ID
- NCT03139318
- Acronym / sponsor ID
- 205993
- Conditions
- Osteosarcoma in Children, Radiation Toxicity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 12 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.
Detailed description
Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GRID Radiotherapy | Experimental | Radiation: GRID radiotherapyPatients will be treated with GRID Radiotherapy |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
- 5-21 years of age.
- Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
- Informed consent is obtained
Key exclusion criteria (2 listed)
- Females with a positive urine pregnancy test.
- Unable to comply with study procedures
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 |
|---|---|---|
| GRID radiotherapyPatients will be treated with GRID radiotherapy | Radiation | GRID Radiotherapy |
Primary outcome
Number of Participants With Toxicities Associated With GRID Radiotherapy
Time frame: An average of 12 months
The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Leslie Harrell, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRID radiotherapy in people with Osteosarcoma in Children and Radiation Toxicity, run by University of Arkansas at 1 site in United States.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 20 Jul 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Toxicities Associated With GRID Radiotherapy (time frame: An average of 12 months). 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 20 Jul 2022.