ClinicalTrials.gov ID: NCT04031677
Protocol: 23-2007
Investigator: Teresa Lee, MD, PhD
Phase: III
Diseases: Retroperitoneal Sarcoma, Liposarcoma, Leiomyosarcoma

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.

Participants will:

Standard arm:

• Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm

Experimental arm:

1. 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
2. Re-assessment of operability
3. Curative-intent surgery within 3-6 weeks of last cycle of chemotherapy

Inclusion Criteria:

• Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis
• Unifocal tumor
• Resectable tumor: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team.
• Tumor not previously treated (no previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy)

Exclusion Criteria

• Metastatic disease
• Persistent myelosuppression
• Uncontrolled cardiac arrhythmia
• Active and uncontrolled infections
• Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow

ClinicalTrials.gov
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Contact Us About This Trial:
For more information about this and other studies and to inquire about eligibility, please call 215-214-1515 or fill out this form.