A Phase 1/2 interventional study of Stereotactic Body Radiotherapy (SBRT) in Ewing Sarcoma, Rhabdomyosarcoma and Wilms Tumor, sponsored by Dana-Farber Cancer Institute. Terminated at 3 sites in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Dana-Farber Cancer Institute · Phase 1/2, Interventional, and Treatment
This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.
This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of these cancers in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.
250 studies on the registry are indexed under Sarcoma, Ewing; 69 are open to participants now.
This study's enrollment of 5 is below the median of 36 across 204 interventional studies indexed under Sarcoma, Ewing.
Browse Sarcoma, Ewing studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with Wilms tumors or other primary renal tumors. Stereotactic Body Radiotherapy (SBRT) Dose Levels for each target lesion are three 8 Gy fractions for 24 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Participants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
Radiation: Stereotactic Body Radiotherapy (SBRT)
Number of Participants With Dose Limiting Toxicity [Phase I]
Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLTs are defined as follows: Grade 2 or higher toxicities: * Myelitis * Esophageal fistula, perforation, hemorrhage Grade 3 or higher toxicities considered to be a direct result of therapy: * Pneumonitis * Pericarditis, pericardial effusion * Esophageal necrosis, stenosis, ulcer * Dyspnea Grade 4 toxicities: * Esophagitis * Pericardial tamponade * Pulmonary toxicity excluding infectious pneumonia * Skin toxicity * Hemoptysis/pulmonary hemorrhage Grade 5 toxicities, including: * Pulmonary toxicity including pneumonitis * Excluding infectious pneumonia Three participants will enter the study in each cohort. If 0/3 patients experiences a DLT, this dose level will move forward to the Phase II and more participants will be enrolled.
Time frame: Up to 6 months
Overall Response Rate [Phase II]
Percentage of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) and Partial Response (PR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter.
Time frame: 6 weeks
Complete Response Rate [Phase II]
Percentage of pulmonary lesions of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions.
Time frame: 6 weeks
2 Year Local Control Rate [Phase II]
Rate of local control (LC) of the index lesion after lung SBRT at 2 years. LC is defined as the absence of tumor progression within 1 cm of the primary tumor site. LC is measured by established methods.
Time frame: 24 Months
Percentage of Participants With 2-Year Failure-Free Survival [Phase II]
Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.
Time frame: 24 months
Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]
Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.
Time frame: Up to 6 months post-treatment (6 months and 2 weeks)
January 2017 to December 2018. No participants were in enrolled in Cohort 1 Dose Level 1 \[Phase I\], Cohort 1 Dose Level 2 \[Phase I\], Cohort 1 Dose Level 3 \[Phase I\], and Cohort 2 Dose Level 3 \[Phase I\]
| Milestone | Cohort 2 Dose Level 2 [Phase I] | Cohort 2 Dose Level 2 [Phase II] |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLTs are defined as follows: Grade 2 or higher toxicities: * Myelitis * Esophageal fistula, perforation, hemorrhage Grade 3 or higher toxicities considered to be a direct result of therapy: * Pneumonitis * Pericarditis, pericardial effusion * Esophageal necrosis, stenosis, ulcer * Dyspnea Grade 4 toxicities: * Esophagitis * Pericardial tamponade * Pulmonary toxicity excluding infectious pneumonia * Skin toxicity * Hemoptysis/pulmonary hemorrhage Grade 5 toxicities, including: * Pulmonary toxicity including pneumonitis * Excluding infectious pneumonia Three participants will enter the study in each cohort. If 0/3 patients experiences a DLT, this dose level will move forward to the Phase II and more participants will be enrolled.
| Participants | Cohort 2 Dose Level 2 [Phase I] |
|---|---|
| Number of Participants With Dose Limiting Toxicity [Phase I] | 0 |
Percentage of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) and Partial Response (PR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter.
| percentage of participants | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Overall Response Rate [Phase II] | 100 (54.9 to 100) |
Percentage of pulmonary lesions of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions.
| percentage of pulmonary lesions | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Complete Response Rate [Phase II] | 75 (39 to 100) |
Rate of local control (LC) of the index lesion after lung SBRT at 2 years. LC is defined as the absence of tumor progression within 1 cm of the primary tumor site. LC is measured by established methods.
| percentage of pulmonary lesions | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| 2 Year Local Control Rate [Phase II] | 60 (19 to 100) |
Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.
| percentage of participants | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Percentage of Participants With 2-Year Failure-Free Survival [Phase II] | 40 (0 to 100) |
Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.
| Participants | Cohort 2 Dose Level 2 [Phase I] | Cohort 2 Dose Level 2 [Phase II] |
|---|---|---|
| Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II] | 0 | 0 |
Collected over Up to 6 months post-treatment (6 months and 2 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 2 Dose Level 2 [Phase I] | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Cohort 2 Dose Level 2 [Phase II] | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Cohort 2 Dose Level 2 [Phase I] | Cohort 2 Dose Level 2 [Phase II] |
|---|---|---|
| FatigueGeneral disorders | 1/3 | 0/2 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/3 | 0/2 |
| Age, Continuous(years) | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Median | 12 (7 to 21) |
| Sex: Female, Male(Participants) | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Female | 2 |
| Male | 3 |
| Race/Ethnicity, Customized(Participants) | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| White | 3 |
| Other | 1 |
| Unknown | 1 |
| Primary Tumor Histologies(Participants) | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Ewing Sarcoma | 3 |
| Anaplastic Chordoma | 1 |
| Osteosarcoma | 1 |
| Number of Lesions(Participants) | Cohort 2 Dose Level 2 [Phase I and II] |
|---|---|
| Two Lesions | 3 |
| One Lesion | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
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