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

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.

Sex

All

Minimum age

18 Years

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.

• BACKGROUNDKosela-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
• BACKGROUNDChung 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
• BACKGROUNDMessiou 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
• BACKGROUNDKosela-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