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

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mazovian
      • Warsaw, Mazovian, Poland, 02-781
        • Maria Sklodowska-Curie Institute - Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2;
  • pathologically confirmed diagnosis of localized, potentially resectable myxoid liposarcoma;
  • primary tumor without previous treatment;
  • extremity or trunk wall localization of the tumor;
  • eligibility for limb-sparing surgery;
  • >= 5cm in the longest diameter at imaging staging (MRI);
  • adequate hematologic, liver, and renal function;
  • women of childbearing potential must have a negative pregnancy test on the day of registration for study;
  • female subjects who are breastfeeding should discontinue nursing prior to the first day of study treatment and during the whole radiotherapy treatment;
  • no co-existing malignancy within the last 2 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
  • the absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial;
  • before patient randomization, written informed consent must be given according to ICH/GCP.

Exclusion Criteria:

  • history of radiation to the affected volume;
  • previous or planned neoadjuvant chemotherapy;
  • contraindications to radiotherapy, or surgery;
  • metastatic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated radiotherapy
5x5 Gy radiotherapy and delayed surgery (after 6-8 weeks)
Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance.
Other Names:
  • 5x5 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complication rate
Time Frame: 6 months
Wound complication rate
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of tumor necrosis
Time Frame: 2 months
2 months
Local control rate
Time Frame: 60 months
Local control rate at 5 years
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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