| Registry | NCT03139318 |
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| Status | Terminated - Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study. |
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| Phase | Not applicable |
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| Study type | Interventional; na, sequential, masking: none, treatment |
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| Enrollment | 1 (Actual) |
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| Sponsor | University of Arkansas (Other) |
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| Conditions | Osteosarcoma in Children, Radiation Toxicity |
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| Interventions | GRID radiotherapy (Radiation) |
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| Dates | start 2017-07-25, primary completion 2018-08-29, completion 2018-08-29, first posted 2017-05-03, last updated 2022-07-20 |
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| Locations | 1 site in United States |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| GRID Radiotherapy | Experimental | Radiation: GRID radiotherapy | Patients will be treated with GRID Radiotherapy |
- GRID radiotherapy (Radiation): Patients will be treated with GRID radiotherapy
+Outcome measures
Primary outcomes
- Number of Participants With Toxicities Associated With GRID Radiotherapy [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.
+Eligibility
Sex: All, ages: 5 Years to 21 Years
Inclusion Criteria:
* 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
Exclusion Criteria:
* Females with a positive urine pregnancy test.
* Unable to comply with study procedures
+Posted results
Participant flow
| Milestone | GRID Radiotherapy |
|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Outcome results
- Number of Participants With Toxicities Associated With GRID Radiotherapy (Primary), Count of participants, Participants: GRID Radiotherapy 1
Adverse events
Time frame: 90 days (+/- 7 days) post surgery
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| GRID Radiotherapy | 0/1 (0.0%) | 0/1 (0.0%) | 1/1 (100.0%) |
Other adverse events by term
| Term | Organ system | GRID Radiotherapy |
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| Surgical wound breakdown (Grade 2) | Surgical and medical procedures | 1/1 |
| Surgical wound breakdown (Grade 3) | Surgical and medical procedures | 1/1 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| University of Arkansas for Medical Sciences | Little Rock, Arkansas | United States | |
+Study documents
+Investigators