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Myxoid LiposarcomaPhase 2LIPOMYXNCT03816475

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

A Phase 2 study testing Hypofractionated radiotherapy in people with Myxoid Liposarcoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myxoid Liposarcoma
What is being tested?
Hypofractionated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 sitePoland
Study dates
24 Apr 2015to Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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;
Show all 13Show fewer
  • >= 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Maria Sklodowska-Curie Institute - Oncology Center

    Warsaw, Mazovian, 02-781

Other trials in Poland

About this study

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

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.

Being tested
Hypofractionated radiotherapy
Keywords
Dose Hypofractionation, Neoadjuvant Therapy, Sarcoma, Dose Fractionation, Dose-Response Relationship
Medical subject headings
Liposarcoma, Myxoid, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated radiotherapyRadiation

    Also called 5x5 Gy

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

Study groups in NCT03816475
Study groupRoleWhat they receive
Hypofractionated radiotherapyExperimental5x5 Gy radiotherapy and delayed surgery (after 6-8 weeks)
Receives: Radiation: Hypofractionated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound complication rate

    Wound complication rate

    Measured: 6 months

Secondary outcomes (2)

  1. Percentage of tumor necrosis

    Measured: 2 months

  2. Local control rate

    Local control rate at 5 years

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2019
  2. Study start24 Apr 2015
  3. Primary completion1 Mar 2019
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03816475
Sponsor's protocol ID
LIPOMYX1
Acronym
LIPOMYX
Status last verified
Jan 2019
First submitted
22 Jan 2019
Last updated
17 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionated radiotherapy in people with Myxoid Liposarcoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound complication rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03816475, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.

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