RecruitingNCT07377747
Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma
Sponsor
Australia and New Zealand Sarcoma Association
Enrollment
100 participants
Start Date
Sep 5, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
The aim of the study is to collect prospective data on the treatment outcomes in patients with first localized, resectable recurrent retroperitoneal well-differentiated and/or dedifferentiated liposarcoma undergoing curative intent treatment. Patients enrolled in this study will form a validation cohort of the TARPSWG recurrent RPS nomogram. The treatment decision (surgery alone, or preoperative RT +/- chemotherapy followed by surgery) is per the institutional multidisciplinary team recommendation.
Eligibility
Min Age: 18 Years
Inclusion Criteria13
- Adult age ≥ 18 presenting with first recurrent well-differentiated and/or dedifferentiated liposarcoma of retroperitoneal space or pelvis after previous macroscopically complete resection (R0/R1 resection)
- No distant metastasis on cross-sectional imaging of chest/abdomen/pelvis (CT and/or MRI) within 1 month to confirm the absence of metastatic disease
- Previous histologically proven well-differentiated or dedifferentiated liposarcoma histology only
- Sarcoma not originating from bone or abdominal or gynecological viscera
- Tumor confirmed to be resectable with likely R0/R1 resection, and all disease must be deemed to be treatable by RT (joint decision by surgeon and radiation oncologist at a sarcoma multidisciplinary team meeting)
- WHO performance status 0-2
- American Society of Anaesthesiologist (ASA) score 1-3
- No prior RT for the retroperitoneal liposarcoma
- Prior systemic therapy is allowed
- No concurrent active malignancy (except for low risk skin malignancy, low risk prostate carcinoma, low risk breast carcinoma including in situ disease)
- Women of childbearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
- Patient deemed able to comply with study requirements according to investigator evaluation
- Signed, IRB-approved written informed consent
Exclusion Criteria5
- Unresectable disease or likely R2 resection as assessed by the multidisciplinary sarcoma team
- Extent of recurrence where preoperative RT to all visible disease is not deemed to be feasible
- Contradiction for RT such as history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
- Myxoid liposarcoma histology
- Pregnancy
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT07377747