Retroperitoneal Liposarcoma
Conditions
Keywords
Sarcoma, liposarcoma, retroperitoneal
Brief 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.
Detailed description
This study is collecting participant data prospectively from hospital medical records. Participant details regarding diagnosis, treatments, outcomes, complications and survival status will be captured after patients are enrolled into the study and at specific time points though out the study. Participants will also be asked to complete quality of life questionnaires called the EORTC QLQ-C30 and the OLO-STO22 at 4 or 5 different time points which will take 15-20 minutes to complete. The overall duration of observation is from time of enrolment for 5 years.
Interventions
None listed
Sponsors
Australia and New Zealand Sarcoma Association
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 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, IRB-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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominopelvic recurrence-free survival (ARFS). . | Up to 5 years. | Defined as the time from the date of treatment start (either surgery, chemo or RT) for 1st recurrent LPS to the date of radiological abdominopelvic relapse or death whichever occurred first. Liver metastases will be regarded as distant metastatic events. rather than abdominopelvic relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 5 years. | Overall survival will be measured from the date of treatment start to the date of death, whatever the cause. Alive patients will be censored during the study and at each follow-up visit (usually every 3-6 months) for up to 5 years. Causes of death will be recorded. |
| Cumulative incidence of 2nd local recurrence (in a competing risk framework) | Up to 5 years. | — |
| Cumulative incidence of distant metastases (in a competing risk framework). | Up to 5 years. | — |
| Cumulative incidence of in-field relapse for those who had preoperative radiotherapy (in a competing risk framework) | Up to 5 years. | — |
| Pathological response using the EORTC-STBSG criteria. | At surgical resection. | Obtained by using the standardised pathological evaluation score for assessing tumour response as recorded in the patient's medical records. |
| Radiology response to preoperative RT. | Within 4 weeks of surgery. | The tumor response will be assessed using RECIST 1.1 and Choi criteria by comparison of baseline cross-sectional imaging (CT-scan or MRI) and preoperative imaging within 4 weeks of surgery (same modality). Response criteria are based on a set of measurable lesions identified at baseline as target lesions and followed at the preoperative imaging performed within 2 weeks of surgery. |
| Local disease progression during preoperative radiotherapy. | During preoperative radiotherapy (for those patients that have preoperative radiotherapy) | Local disease progression during preoperative radiotherapy rendering disease no longer operable |
| Distant disease progression during preoperative RT. | During preoperative radiotherapy (for those patients that have preoperative radiotherapy). | — |
| Toxicity of preoperative radiotherapy | From the start of preoperative radiotherapy up to one week prior to surgery | — |
| Surgical complication | Up to 60 days post surgery | — |
| Health related quality of life using the EORTC QLQ-C30 and the EORTC QLQ-STO22 assessment scales. | At registration, during the last week of RT treatment (preoperative RT patients only), within 2 weeks prior to surgery (for the preoperative RT patients), at 3 months and 12 months after surgery. | The QLQ-C30 (core questionnaire) and the QLQ-STO22 (gastric cancer-specific module) are used together. Scores range from 0-100 with higher scores meaning better quality of life. |
| Unplanned R2 resection | At surgery | — |
| Stratified analysis of use of chemotherapy | Up to 5 years. | — |
| Validation of the recurrent RPS nomogram and the dynamic primary RPS nomogram | Up to 5 years. | — |
Countries
Australia, Belgium, Brazil, Canada, France, Netherlands, Poland, United States
Contacts
CONTACTJanina Chapman
PRINCIPAL_INVESTIGATORAngela Hong
Chris O'Brien Lifehouse
Outcome results
None listed