About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Ultra-Hypo-fractionation Radiotherapy
RadiationFive fractions of pre-operative radiation
Resection
Procedure/SurgerySurgery
Questionnaire Administration
Other interventionAncillary studies
Moderately-Hypo-fractionation Radiotherapy
Radiation15 fractions of pre-operative radiation
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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