Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 28, 2025
March 1, 2025
5.3 years
August 5, 2020
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Complication rate
Approximately 2 years
Study Arms (2)
Group I (UH HRT)
EXPERIMENTALPatients undergo HRT daily for a total of 5 fractions followed by surgery.
Group II (MH HRT)
EXPERIMENTALPatients undergo HRT daily for a total of 15 fractions followed by surgery.
Interventions
Five fractions of pre-operative radiation
15 fractions of pre-operative radiation
Eligibility Criteria
You may qualify if:
- Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
- ECOG performance status 0-2
- Patient must be deemed able to comply with radiation treatment and surgery
You may not qualify if:
- History of prior radiation to the same area to be irradiated
- Pregnancy
- Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Shinohara, MD
Vanderbilt Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 10, 2020
Study Start
March 2, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
March 28, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share