Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperi… (NCT07377747) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma
United States, Australia100 participantsStarted 2024-09-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Abdominopelvic recurrence-free survival (ARFS). .
Timeframe: Up to 5 years.
Trial details
NCT IDNCT07377747
SponsorAustralia and New Zealand Sarcoma Association