Osteosarcoma in Children, Radiation Toxicity
Conditions
Brief 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.
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.
Interventions
RADIATIONGRID radiotherapy
Patients will be treated with GRID radiotherapy
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GRID Radiotherapy Patients will be treated with GRID Radiotherapy
GRID radiotherapy: Patients will be treated with GRID radiotherapy | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | GRID Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: An average of 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GRID Radiotherapy | Number of Participants With Toxicities Associated With GRID Radiotherapy | 1 Participants |