An interventional study of GRID radiotherapy in Osteosarcoma in Children and Radiation Toxicity, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment
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.
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.
437 studies on the registry are indexed under Osteosarcoma; 116 are open to participants now.
This study's enrollment of 1 is below the median of 42 across 325 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with GRID Radiotherapy
Radiation: GRID radiotherapy
Patients will be treated with GRID radiotherapy
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.
Time frame: An average of 12 months
| Milestone | GRID Radiotherapy |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.
| Participants | GRID Radiotherapy |
|---|---|
| Number of Participants With Toxicities Associated With GRID Radiotherapy | 1 |
Collected over 90 days (+/- 7 days) post surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GRID Radiotherapy | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | GRID Radiotherapy |
|---|---|
| Surgical wound breakdown (Grade 2)Surgical and medical procedures | 1/1 |
| Surgical wound breakdown (Grade 3)Surgical and medical procedures | 1/1 |
| Age, Categorical(Participants) | GRID Radiotherapy |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | GRID Radiotherapy |
|---|---|
| Female | 0 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | GRID Radiotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | GRID Radiotherapy |
|---|---|
| United States | 1 |
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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Arkansas