Based upon the preliminary data derived from first SCOPES clinical trial and the results of patients treated during the recent COVID-19 pandemic, patients with soft tissue sarcomas (STS) can be preoperatively irradiated in a modestly hypofractionated schedule of 14 x 3 Gy. From a toxicity and efficacy point of view, this regimen equals the outcomes after a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Moreover, the rationale for investigating (modest) hypofractionation in the clinic comes both from a logistic point of view (patient convenience and a lower pressure on radiotherapy equipment), form prior phase II clinical evidence and from (cellular) radiobiological observations. There is phase II trial evidence suggesting that even more (ultra-) hypofractionation to 5 x 6 Gy is also safe and effective. Within this study, patients will be randomized to receive either the modestly hypofractionated conventional schedule of 14 x 3 Gy or an even shorter preoperative regimen of 5 x 6 Gy, in the hypothesis that both the postoperative wound complication rate until 120 days after surgery, as well as the local control probability at two years are comparable in both arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
preoperative radiotherapy
Netherlands Cancer Institute
Amsterdam, Netherlands
NOT_YET_RECRUITINGAUMC
Amsterdam, Netherlands
RECRUITINGUMCG
Groningen, Netherlands
NOT_YET_RECRUITINGLUMC
Leiden, Netherlands
NOT_YET_RECRUITINGMaastro
Maastricht, Netherlands
RECRUITINGRadboudUMC
Nijmegen, Netherlands
NOT_YET_RECRUITINGThe short-term toxicity
wound complications
Time frame: within 120 days post-surgery
Local control
local failure after surgery
Time frame: During follow up (5 years)
Long-term toxicity
fibrosis, edema, joint stiffness and bone fractures
Time frame: During follow-up (5 years)
Not operated patients
Outcome of patients that were irradiated per randomization but eventually were not operated upon in conjunction to the reasons why the operation was not executed
Time frame: During follow-up (5 years)
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