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Status unknownNCT03816475LIPOMYXUpdated Jun 17, 2019

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

A Phase 2 interventional study of Hypofractionated radiotherapy in Myxoid Liposarcoma, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Apr 2015, registered Jan 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Myxoid Liposarcoma

Keywords

  • Dose Hypofractionation
  • Neoadjuvant Therapy
  • Sarcoma
  • Dose Fractionation
  • Dose-Response Relationship
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In context

Liposarcoma

143 studies on the registry are indexed under Liposarcoma; 37 are open to participants now.

This study's planned enrollment of 35 is below the median of 40 across 119 interventional studies indexed under Liposarcoma.

Browse Liposarcoma studies →

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • history of radiation to the affected volume;
  • previous or planned neoadjuvant chemotherapy;
  • contraindications to radiotherapy, or surgery;
  • metastatic disease.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Hypofractionated radiotherapy

    5x5 Gy radiotherapy and delayed surgery (after 6-8 weeks)

    Radiation: Hypofractionated radiotherapy

Interventions

  • RadiationHypofractionated radiotherapy

    Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance.

    Also known as: 5x5 Gy

06

What researchers measure

Primary outcomes

  1. Wound complication rate

    Wound complication rate

    Time frame: 6 months

Secondary outcomes

  1. Percentage of tumor necrosis

    Time frame: 2 months

  2. Local control rate

    Local control rate at 5 years

    Time frame: 60 months

07

Study locations

1 site
  • Maria Sklodowska-Curie Institute - Oncology Center
    Warsaw, Mazovian 02-781, Poland
08

References and documents

Publications

  • Kosela-Paterczyk H, Szacht M, Morysinski T, Lugowska I, Dziewirski W, Falkowski S, Zdzienicki M, Pienkowski A, Szamotulska K, Switaj T, Rutkowski P. Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Eur J Surg Oncol. 2014 Dec;40(12):1641-7. doi: 10.1016/j.ejso.2014.05.016. Epub 2014 Sep 20. PubMed 25282099 ↗
  • Chung PW, Deheshi BM, Ferguson PC, Wunder JS, Griffin AM, Catton CN, Bell RS, White LM, Kandel RA, O'Sullivan B. Radiosensitivity translates into excellent local control in extremity myxoid liposarcoma: a comparison with other soft tissue sarcomas. Cancer. 2009 Jul 15;115(14):3254-61. doi: 10.1002/cncr.24375. PubMed 19472403 ↗
  • Messiou C, Bonvalot S, Gronchi A, Vanel D, Meyer M, Robinson P, Morosi C, Bloem JL, Terrier PH, Lazar A, Le Pechoux C, Wardelman E, Winfield JM, Boulet B, Bovee J, Haas RL. Evaluation of response after pre-operative radiotherapy in soft tissue sarcomas; the European Organisation for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG) and Imaging Group recommendations for radiological examination and reporting with an emphasis on magnetic resonance imaging. Eur J Cancer. 2016 Mar;56:37-44. doi: 10.1016/j.ejca.2015.12.008. Epub 2016 Jan 20. PubMed 26802529 ↗
  • Kosela-Paterczyk H, Szumera-Cieckiewicz A, Szacht M, Haas R, Morysinski T, Dziewirski W, Prochorec-Sobieszek M, Rutkowski P. Efficacy of neoadjuvant hypofractionated radiotherapy in patients with locally advanced myxoid liposarcoma. Eur J Surg Oncol. 2016 Jun;42(6):891-8. doi: 10.1016/j.ejso.2016.02.258. Epub 2016 Mar 18. PubMed 27026512 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03816475
Lead sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Responsible party
Sponsor
First posted
Jan 25, 2019
Start date
Apr 24, 2015
Primary completion
Mar 1, 2019
Completion
Feb 2024 (estimated)
Last update
Jun 17, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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