At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Surgery (procedure), Preoperative chemotherapy (drug)
- How long the study runs
- Study runs about 87 months (dates as stated)
- About the drug or intervention
- Surgery — procedure: Large en-bloc curative-intent surgery · Preoperative chemotherapy — drug: * High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks * LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks Note: the recommended dose of Doxorubicin (or Epirubicin) can be modified according to national/institutional guidelines, given that the minimal threshold must be Doxorubicin 60 mg/m2 per cycle (or the equivalent Epirubicin 95 mg/m2 per cycle); the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimal threshold must be 7.5 g/m2 per cycle; the recommended dose of Dacarbazine can be modified according to national/institutional guidelines, given that the minimal threshold must be 900 mg/m2 per cycle.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 250
- Started
- 2021-01-20
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for retroperitoneal sarcoma
- • Phase3 - 250 participants
- • This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with retroperitoneal sarcoma
Where?
- • Birmingham - University Hospitals Birmingham - Queen Elisabeth Medical Centre
- • Glasgow - NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
- • Leeds - Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
- • London - the Royal Marsden Hospital
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
More detail
Standard arm: * Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm Experimental arm: * 3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization: * High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks. * LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks * re-assessment of operability * curative-intent surgery within 3-6 weeks of last cycle of chemotherapy
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ radiologically measurable disease (RECIST 1
- ✓ and if the patient fulfils all other eligibility criteria, he/she will be eligible
- ✓ a negative serum pregnancy test within 3 days
What the study is looking for
- ✓Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or...
- ✓Any grade LMS can be included
- ✓Minimum size of LMS tumor should be 5 cm
- ✓All grade 3 DDLPS can be included.
- ✓DDLPS with confirmed grade 2 on biopsy can be included when:
Who cannot take part
- ✗Sarcoma originating from bone structure, abdominal or gynecological viscera
- ✗Extension through the sciatic notch or across the diaphragm
- ✗that has spread disease
- ✗Any previous surgery (excluding diagnostic biopsy), radiotherapy or treatment that goes through your whole body for the present tumour
- ✗Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
See the full criteria
Where Is This Study? (8 UK sites)
University Hospitals Birmingham - Queen Elisabeth Medical Centre
Birmingham B15 2TH, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds LS9 7TF, United Kingdom
the Royal Marsden Hospital
London, United Kingdom
Clatterbridge cancer center
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care
Newcastle NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham NG5 1PB, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford OX3 7LE, United Kingdom
How to Get in Touch
EORTC HQ
Sponsor contactCONTACT
