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The study closed primarily due to weak accrual, as well as study design limitations.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Dose Level 1 [Phase I] | Experimental | 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. |
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| Cohort 1 Dose Level 2 [Phase I] | Experimental | 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. |
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| Cohort 1 Dose Level 3 [Phase I] | Experimental | 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. |
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| Cohort 2 Dose Level 2 [Phase I] | Experimental | Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. |
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| Cohort 2 Dose Level 3 [Phase I] | Experimental | Participants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
Grade 3 or higher toxicities considered to be a direct result of therapy:
Grade 4 toxicities:
Grade 5 toxicities, including:
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. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Marcus, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33305087 | Result | Liu KX, Chen YH, Kozono D, Mak RH, Boyle PJ, Janeway KA, Mullen EA, Marcus KJ. Phase I/II Study of Stereotactic Body Radiation Therapy for Pulmonary Metastases in Pediatric Patients. Adv Radiat Oncol. 2020 Sep 23;5(6):1267-1273. doi: 10.1016/j.adro.2020.09.004. eCollection 2020 Nov-Dec. |
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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]
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 2 Dose Level 2 [Phase I] | Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. Stereotactic Body Radiotherapy (SBRT) |
| FG001 | Cohort 2 Dose Level 2 [Phase II] |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2019 |
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| Cohort 2 Dose Level 2 [Phase II] | Experimental | Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. |
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| 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. | 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. | 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. | Up to 6 months post-treatment (6 months and 2 weeks) |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. Stereotactic Body Radiotherapy (SBRT) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 2 Dose Level 2 [Phase I and II] | Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. Stereotactic Body Radiotherapy (SBRT) |
| 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, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary Tumor Histologies | Count of Participants | Participants |
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| Number of Lesions | Count of Participants | Participants |
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| 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 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:
Grade 3 or higher toxicities considered to be a direct result of therapy:
Grade 4 toxicities:
Grade 5 toxicities, including:
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. | Posted | Count of Participants | Participants | Up to 6 months |
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| Primary | 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. | It is pre-specified in the protocol that Phase I and Phase II populations for each cohort are combined for this analysis | Posted | Number | 90% Confidence Interval | percentage of participants | 6 weeks |
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| Secondary | 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. | It is pre-specified in the protocol that Phase I and Phase II populations for each cohort are combined for this analysis | Posted | Number | 95% Confidence Interval | percentage of pulmonary lesions | 6 weeks | lesions | lesions |
|
| ||||||||||||||||||||||||
| Secondary | 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. | It is pre-specified in the protocol that Phase I and Phase II populations for each cohort are combined for this analysis | Posted | Number | 95% Confidence Interval | percentage of pulmonary lesions | 24 Months | Lesions | Lesions |
|
| ||||||||||||||||||||||||
| Secondary | 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. | It is pre-specified in the protocol that Phase I and Phase II populations for each cohort are combined for this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
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| ||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 6 months post-treatment (6 months and 2 weeks) |
|
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Up to 6 months post-treatment (6 months and 2 weeks)
Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
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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 | Cohort 2 Dose Level 2 [Phase I] | Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. Stereotactic Body Radiotherapy (SBRT) | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | Cohort 2 Dose Level 2 [Phase II] | Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total. Stereotactic Body Radiotherapy (SBRT) | 0 | 2 | 0 | 2 | 0 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCA v4.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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The study had small sample size / weak accrual.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Marcus MD | Dana-Farber Cancer Institute | 16177328783 | karen_marcus@dfci.harvard.edu |
| Mar 5, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D009396 | Wilms Tumor |
| D012516 | Osteosarcoma |
| D012509 | Sarcoma |
| D002292 | Carcinoma, Renal Cell |
| D018335 | Rhabdoid Tumor |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Unknown |
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| Osteosarcoma |
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