Status:
UNKNOWN
Hypofractionated Radiotherapy in Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall (LIPO-MYX Trial)
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Myxoid Liposarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Multidiscipli...
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...
Eligibility Criteria
Inclusion
- ≥ 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
- history of radiation to the affected volume;
- previous or planned neoadjuvant chemotherapy;
- contraindications to radiotherapy, or surgery;
- metastatic disease.
Key Trial Info
Start Date :
April 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03816475
Start Date
April 24 2015
End Date
February 1 2024
Last Update
June 17 2019
Active Locations (1)
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1
Maria Sklodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, Poland, 02-781