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

NCT03816475 | Unknown Phase 2

• 1 other identifier: LIPOMYX1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Myxoid Liposarcoma

Keywords

Dose Hypofractionation; Neoadjuvant Therapy; Sarcoma; Dose Fractionation; Dose-Response Relationship

Outcome Measures

Primary Outcomes (1)

• Wound complication rate

  Wound complication rate

  6 months

Secondary Outcomes (2)

• Percentage of tumor necrosis

  2 months

• Local control rate

  60 months

Study Arms (1)

Hypofractionated radiotherapy

EXPERIMENTAL

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

Radiation: Hypofractionated radiotherapy

Interventions

Hypofractionated radiotherapy RADIATION

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

Hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, Mazovian, 02-781, Poland

Location

Related Publications (4)

• 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.

  PMID: 25282099 BACKGROUND

• 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.

  PMID: 19472403 BACKGROUND

• 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.

  PMID: 26802529 BACKGROUND

• 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.

  PMID: 27026512 BACKGROUND

MeSH Terms

Conditions

Liposarcoma, Myxoid; Sarcoma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Liposarcoma; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: April 24, 2015
• Primary Completion: March 1, 2019
• Study Completion: February 1, 2024
• Last Updated: June 17, 2019

Record last verified: 2019-01

Locations

PL (1)