Myxoid Liposarcoma Clinical Trial
— LIPOMYXOfficial 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
Verified date | January 2019 |
Source | Maria Sklodowska-Curie Institute - Oncology Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 35 |
Est. completion date | February 2024 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Poland | Maria Sklodowska-Curie Institute - Oncology Center | Warsaw | Mazovian |
Lead Sponsor | Collaborator |
---|---|
Maria Sklodowska-Curie Institute - Oncology Center |
Poland,
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. — View Citation
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. — View Citation
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. — View Citation
Messiou C, Bonvalot S, Gronchi A, Vanel D, Meyer M, Robinson P, Morosi C, Bloem JL, Terrier PH, Lazar A, Le Péchoux C, Wardelman E, Winfield JM, Boulet B, Bovée 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound complication rate | Wound complication rate | 6 months | |
Secondary | Percentage of tumor necrosis | 2 months | ||
Secondary | Local control rate | Local control rate at 5 years | 60 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01957709 -
Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
|
Early Phase 1 | |
Active, not recruiting |
NCT03600649 -
Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas
|
Phase 1 | |
Completed |
NCT02821507 -
Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma
|
Phase 2 | |
Withdrawn |
NCT03397186 -
Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma
|
Phase 2 | |
Active, not recruiting |
NCT03989596 -
Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas
|
Phase 2 | |
Recruiting |
NCT04699292 -
International Prospective Registry on Local Treatment Approaches in MLS
|
||
Enrolling by invitation |
NCT05266196 -
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)
|
Phase 1/Phase 2 | |
Recruiting |
NCT05492682 -
START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03651375 -
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall
|
Phase 2 | |
Active, not recruiting |
NCT00633165 -
Brostallicin Clinical Trial for Myxoid Liposarcoma
|
Phase 2 | |
Recruiting |
NCT04044768 -
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
|
Phase 2 |