ACTRN12624000554561RecruitingUnknown
Prospective Study Evaluating The Treatment Outcomes For Localised Recurrent, Resectable Retroperitoneal Liposarcoma in adults.
Australia and New Zealand Sarcoma Association0 sites100 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1. Aged 18 years or older presenting with first recurrent well-differentiated and/or dedifferentiated liposarcoma of retroperitoneal space or pelvis after previous macroscopically complete resection (R0/R1 resection)
- •2. 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
- •3. Previous histologically proven well-differentiated or dedifferentiated liposarcoma histology only
- •4. Sarcoma not originating from bone or abdominal or gynecological viscera
- •5. 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)
- •6. WHO performance status 0-2
- •7. American Society of Anaesthesiologist (ASA) score 1-3
- •8. No prior RT for the retroperitoneal liposarcoma
- •9. Prior systemic therapy is allowed
- •10. No concurrent active malignancy (except for low risk skin malignancy, low risk prostate carcinoma, low risk breast carcinoma including in situ disease)
- •11. Women of childbearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
- •12. Patient deemed able to comply with study requirements according to investigator evaluation
- •13. Signed ethics approved written informed consent
Exclusion Criteria
- •1. Unresectable disease or likely R2 resection as assessed by the multidisciplinary sarcoma team
- •2. Extent of recurrence where preoperative RT to all visible disease is not deemed to be feasible
- •3. Contradiction for RT such as history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
- •4. Myxoid liposarcoma histology
- •5. Pregnancy
Investigators
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