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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-0360 | Other Identifier | Institutional Review Board | |
| A533300 | Other Identifier | UW Madison | |
| SMPH/HUMAN ONCOLOGY/HUMAN ONCO | Other Identifier | UW Madison | |
| NCI-2019-03768 | Registry Identifier | NCI Trial ID | |
| Protocol Version 5/5/2021 | Other Identifier | UW Madison |
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One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation.
Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiotherapy for Soft Tissue Sarcoma | Experimental | Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiotherapy | Radiation | Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With 2-year Local Control | The primary endpoint is 2-year local control, defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Progressive Disease (PD), at least a 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient change for PR, PD, or CR. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site | 2-year local control rates will be reported separately for primary sites vs. metastatic sites. | up to 2 years |
| Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary Morris, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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Participants were enrolled at UW Health Hospital from June 2019 to November 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypofractionated Radiotherapy for Soft Tissue Sarcoma | Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypofractionated Radiotherapy for Soft Tissue Sarcoma | Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Proportion of Participants With 2-year Local Control | The primary endpoint is 2-year local control, defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Progressive Disease (PD), at least a 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient change for PR, PD, or CR. | Posted | Number | proportion of participants | up to 2 years |
|
Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.
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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 | Hypofractionated Radiotherapy for Soft Tissue Sarcoma | Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks. Hypofractionated Radiotherapy: Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jejunal perforation | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zachary Morris, MD, PhD | UW School of Medicine and Public Health | (608) 263-2603 | zmorris@humonc.wisc.edu |
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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 | May 5, 2021 | Oct 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI. |
| up to 5 years |
| Complete Response Rate | The complete response (CR) rate will be reported with an exact 95% CI. | up to 5 years |
| Progression Free Survival | Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method. | up to 5 years |
| Overall Survival | Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method. | up to 5 years |
| Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade | Unique toxicities tabulated by type and grade. | up to 8 weeks |
| Incidence of Long Term Toxicity | Tabulated by type and grade. | up to 5 years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| Secondary | Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site | 2-year local control rates will be reported separately for primary sites vs. metastatic sites. | Only 22 patients were alive at 2 years to be evaluated for this measure OR had already experienced local failure and ALSO were evaluated with imaging | Posted | Number | proportion of participants | up to 2 years |
|
|
|
| Secondary | Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site | 5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI. | Not Posted | up to 5 years | Participants |
| Secondary | Complete Response Rate | The complete response (CR) rate will be reported with an exact 95% CI. | Not Posted | up to 5 years | Participants |
| Secondary | Progression Free Survival | Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method. | Not Posted | up to 5 years | Participants |
| Secondary | Overall Survival | Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method. | Not Posted | up to 5 years | Participants |
| Secondary | Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade | Unique toxicities tabulated by type and grade. | Posted | Count of Participants | Participants | No | up to 8 weeks |
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|
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| Secondary | Incidence of Long Term Toxicity | Tabulated by type and grade. | Not Posted | up to 5 years | Participants |
| 27 |
| 48 |
| 1 |
| 48 |
| 23 |
| 48 |
| Anxiety | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Decreased Range of Motion | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Fibrosis | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Lymphedema | Immune system disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Pain | General disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Radiation dermatitis | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Anxiety |
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| Arthralgia |
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| Decreased Range of Motion |
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| Diarrhea |
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| Erthema multiforme |
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| Esophagitis |
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| Fatigue |
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| Fibrosis |
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| Insomnia |
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| Lymphedema |
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| Muscle Weakness |
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| Myositis |
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| Nausea |
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| Pain |
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| Radiation Dermatitis |
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| Vomiting |
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