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The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Study Objectives:
Primary:
OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.
GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.
GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.
After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (UH HRT) | Experimental | Patients undergo HRT daily for a total of 5 fractions followed by surgery. |
|
| Group II (MH HRT) | Experimental | Patients undergo HRT daily for a total of 15 fractions followed by surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-Hypo-fractionation Radiotherapy | Radiation | Five fractions of pre-operative radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate | Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported. | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. | Approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanderbilt-Ingram Service for Timely Access | Contact | 800-811-8480 | cip@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Eric Shinohara, MD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2023 | Nov 8, 2023 |
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| Resection | Procedure | Surgery |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Moderately-Hypo-fractionation Radiotherapy | Radiation | 15 fractions of pre-operative radiation |
|
| ICF_000.pdf |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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