Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
NCT ID: NCT04506008
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2021-03-02
2027-06-30
Brief Summary
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Detailed Description
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Primary:
* To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
* Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.
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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group I (UH HRT)
Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Ultra-Hypo-fractionation Radiotherapy
Five fractions of pre-operative radiation
Resection
Surgery
Questionnaire Administration
Ancillary studies
Group II (MH HRT)
Patients undergo HRT daily for a total of 15 fractions followed by surgery.
Resection
Surgery
Questionnaire Administration
Ancillary studies
Moderately-Hypo-fractionation Radiotherapy
15 fractions of pre-operative radiation
Interventions
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Ultra-Hypo-fractionation Radiotherapy
Five fractions of pre-operative radiation
Resection
Surgery
Questionnaire Administration
Ancillary studies
Moderately-Hypo-fractionation Radiotherapy
15 fractions of pre-operative radiation
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-2
* Patient must be deemed able to comply with radiation treatment and surgery
Exclusion Criteria
* Pregnancy
* Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
18 Years
ALL
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Eric Shinohara
Principal Investigator
Principal Investigators
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Eric Shinohara, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VICC SAR 2062
Identifier Type: -
Identifier Source: org_study_id
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