Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Conditions
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Soft Tissue Sarcomas

Intervention / Treatment
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* Radiation: Ultra-Hypo-fractionation Radiotherapy
* Procedure: Resection
* Other: Questionnaire Administration
* Radiation: Moderately-Hypo-fractionation Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (UH HRT)<br>Patients undergo HRT daily for a total of 5 fractions followed by surgery. | Radiation: Ultra-Hypo-fractionation Radiotherapy<br>* Five fractions of pre-operative radiation<br>Procedure: Resection<br>* Surgery<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (MH HRT)<br>Patients undergo HRT daily for a total of 15 fractions followed by surgery. | Procedure: Resection<br>* Surgery<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Radiation: Moderately-Hypo-fractionation Radiotherapy<br>* 15 fractions of pre-operative radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypofractionated Radiotherapy