Preoperative intensity modulated radiation therapy
Radiation50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision
NCT Number: NCT02565498
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 3
Cliniques Universitaires Saint-Luc, Brussels, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision
Surgery followed by 50 Gy delivered in 25 fractions within 6 weeks of surgery for patients with negative margins; for patients with positive margins a boost of 16 Gy in 8 fractions will be added.
Time frame: 120 days post surgery
Time frame: Once per week from the start of radiotherapy until its completion (5 weeks in total), then 1 week preop for Group 1; 4 weeks post completion of treatment for Group 2
Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
Time frame: Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.
Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
Time frame: Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.
Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0
Time frame: Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.
Peripheral limb edema will be documented according to the Late Limb Edema Scoring Criteria.
Time frame: Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.
Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale.
Time frame: Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.
Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS)
Time frame: Surgery Date until 5 years postoperative or death, whichever occurs first
Overall patient survival in months during the study period
Time frame: Surgery date until 5 years postoperative or local recurrence, whichever occurs first.
Patient survival without a local recurrence in months during the study period.
Time frame: Surgery date until 5 years postoperative or systemic recurrence, whichever occurs first.
Patient survival without systemic metastases in months during the study period.
Mount Sinai Hospital, Canada
Other
Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma
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