Bone Sarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma
Conditions
Keywords
proton beam radiation
Brief summary
The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.
Detailed description
* Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment. * A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated.
Interventions
RADIATIONProton Beam Radiation
Once per day, 5 days a week for a total of 4 to 6 weeks.
Sponsors
Brigham and Women's Hospital
Boston Children's Hospital
Dana-Farber Cancer Institute
National Institutes of Health (NIH)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy proven Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) or bone sarcoma * Less than or equal to 30 years of age * Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated * Patients must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment * They or their legal guardian must give their informed consent * Timing of radiation may be according to concurrent protocol
Exclusion criteria
* Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease * Patients who are pregnant * Previous treatment with radiation therapy * Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment | 5 years from the completion of radiation treatment | Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur \> 90 days following completion of radiation. |
| Local Control | 5 years from the start of radiation treatment | Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetric Comparison | 5 years | Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proton Beam Radiation Proton Beam Radiation
Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Proton Beam Radiation |
|---|---|
| Age, Continuous | 12.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 4 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 69 |
| other Total, other adverse events | 69 / 69 |
| serious Total, serious adverse events | 8 / 69 |
Outcome results
Primary
Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment
Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur \> 90 days following completion of radiation.
Time frame: 5 years from the completion of radiation treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proton Beam Radiation | Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment | 17.7 percentage of participants |
95% CI: [9.1, 27.6]
Primary
Local Control
Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred.
Time frame: 5 years from the start of radiation treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proton Beam Radiation | Local Control | 87.1 percentage of participants |
95% CI: [78.1, 93.7]
Secondary
Dosimetric Comparison
Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
Time frame: 5 years
Population: Data were not collected and this outcome was not analyzed. DVH's were not generated for these patients. Data will not be collected in the future. The decision not to generate photon/proton contours DVH's was at the discretion of the dosimetrist/treating physician.