Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Local control rate
Study Overview
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.
Detailed Description
Study Objectives:
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Group I (UH HRT)
Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Intervention: Resection (Procedure)
Group I (UH HRT)
Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Intervention: Ultra-Hypo-fractionation Radiotherapy (Radiation)
Group I (UH HRT)
Patients undergo HRT daily for a total of 5 fractions followed by surgery.
Intervention: Questionnaire Administration (Other)
Group II (MH HRT)
Patients undergo HRT daily for a total of 15 fractions followed by surgery.
Intervention: Resection (Procedure)
Group II (MH HRT)
Patients undergo HRT daily for a total of 15 fractions followed by surgery.
Intervention: Questionnaire Administration (Other)
Group II (MH HRT)
Patients undergo HRT daily for a total of 15 fractions followed by surgery.
Intervention: Moderately-Hypo-fractionation Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Local control rate
Time Frame: Approximately 2 years
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.
Secondary Outcomes
- Complication rate(Approximately 2 years)
Investigators
Eric Shinohara
Principal Investigator
Vanderbilt-Ingram Cancer Center