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Spots Global Cancer Trial Database for Hypofractionated Radiotherapy in Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall (LIPO-MYX Trial)

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Trial Identification

Brief Title: Hypofractionated Radiotherapy in Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall (LIPO-MYX Trial)

Official Title: Hypofractionated 5x5 Gy Radiotherapy With Prolonged Gap Before Surgery in Preoperative Treatment of Patients With Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall

Study ID: NCT03816475

Study Description

Brief Summary: After a screening, which consists of pathology confirmation, physical examination, magnetic resonance imaging (MRI), body computed tomography (CT) scan, blood tests, and case analysis on Multidisciplinary Team (MDT) meeting, patient will be irradiated 5x5 Gy and after radiotherapy and then referred for surgery 6-8 weeks after the radiotherapy completion.

Detailed Description: Myxoid liposarcoma has been reported to be more radiosensitive compared with other soft tissue sarcomas (STS). Response to preoperative treatment involves in decrease in tumor size, a large percentage in tumor necrosis (which according to some reports has a beneficial effect on the reduction of local recurrence rates) and also among other in a change in vasculature of the tissue. Hypofractionation represents a variation of radiotherapy fractionation in which the total dose is divided into fewer fractions with an increased fraction dose. Such treatment may lead to additional biological effects when compared to conventionally fractionated radiotherapy (eg. vascular damage, increased immunogenicity, and antigenicity). The main advantages of hypofractionation are those related to the decreased overall treatment time what is more convenient for both patients and physicians, increased compliance and makes the treatment more cost-effective. Intriguing, such an approach may provide an additional benefit when treating non-radiosensitive tumors with a low alpha/beta ratio (eg. sarcomas). The use of preoperative hypofractionated radiotherapy 5x5 Gy for five consecutive days, and then immediate surgery in patients with locally advanced soft tissue sarcomas showed in a published study a good local control rate, with a favorable amount of late toxicities. In this patient population, there were 22 patients with primary myxoid liposarcoma and the local control rate in this group was 86%. In the proposed study we plan to increase the gap between the end of radiotherapy and surgery to commonly applied five weeks to better assess the changes occurring in the tumor after treatment and to evaluate the impact of longer treatment interval on reducing the proportion of early complications of treatment.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Mazovian, Poland

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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