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Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRID Radiotherapy | Experimental | Patients will be treated with GRID Radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRID radiotherapy | Radiation | Patients will be treated with GRID radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | An average of 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Harrell, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GRID Radiotherapy | Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GRID Radiotherapy | Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | An average of 12 months |
|
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90 days (+/- 7 days) post surgery
The PI must be notified within 24 hours of learning of any serious adverse events, regardless of attribution, occurring during the study. The IRB must be notified within 10 business days of any unanticipated problems involving risk to subjects or others. All other adverse events, such as those that are expected, or are unlikely or definitely not related to the study participation, are to be reported annually as part of regular IRB continuing review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GRID Radiotherapy | Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical wound breakdown (Grade 2) | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Scanlan | University of Arkansas for Medical Sciences | 5016868274 | bscanlan@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 9, 2020 | Jun 15, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| Surgical wound breakdown (Grade 3) | Surgical and medical procedures | Systematic Assessment |
|
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