This study is designed to determine if preoperative image guided radiation therapy (IGRT)
delivered using intensity modulated radiation therapy (IMRT) followed by surgery results
in similar short-term wound healing complications as surgery followed by postoperative
IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will
receive preoperative radiotherapy, half will receive postoperative radiotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02565498.
Perioperative RT in addition to surgery is widely accepted as standard management for
soft tissue sarcoma (STS) of the extremity and trunk. However, controversy remains as to
whether RT should be delivered preoperatively or postoperatively. While both confer
similar rates of local control, preoperative RT leads to a decrease in late tissue
morbidities such as fibrosis, limb edema, joint stiffness and fracture as compared to
postoperative RT. The reasons for this are likely multifactorial, but are in part related
to total dose delivered (50 Gray (GY) preoperatively and 60-66 Gy postoperatively) and,
based on a previous National Cancer Institute (Canada) Phase III randomized controlled
trial, the much larger volume treated in the postoperative setting compared to that in
the preoperative setting. The optimal radiation dose used in the postoperative setting is
unknown but has been developed empirically and doses of 60-66 Gy are generally
employed.However, investigators in Norway/Sweden and France have found equivalent local
control rates for patients with negative surgical margins treated with 50 GY
postoperativelyThe main concern with preoperative RT has centered on the risk of an
increased rate of delayed wound healing and major wound complications. Although some
studies suggest it may be possible to reduce the incidence of acute wound healing
complications associated with pre-operative radiation than previously seen in the 2D RT
era, this has yet to be tested in the phase III setting. IG-IMRT allows a much higher
degree of conformality and accurate delivery of dose to the tumour while sparing
surrounding normal tissue. This may allow similar rates of acute wound healing
complications for pre- and postoperative RT in the treatment of STS.
Lead OrganizationMount Sinai Hospital
