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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery with preoperative radiotherapy | This includes patient who have had any chemotherapy. | ||
| Surgery without preoperative radiotherapy | This includes patients who had surgery alone, surgery with postoperative radiotherapy and/or any chemotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Abdominopelvic recurrence-free survival (ARFS). . | 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 | Up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 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. | Up to 5 years. |
| Cumulative incidence of 2nd local recurrence (in a competing risk framework) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with localized, resectable recurrent retroperitoneal liposarcoma attending and having treatment at the study site.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janina Chapman | Contact | 61414316490 | janina.chapman@petermac.org |
| Name | Affiliation | Role |
|---|---|---|
| Angela Hong | Chris O'Brien Lifehouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| 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. | Obtained by using the standardised pathological evaluation score for assessing tumour response as recorded in the patient's medical records. | At surgical resection. |
| Radiology response to preoperative RT. | 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. | Within 4 weeks of surgery. |
| Local disease progression during preoperative radiotherapy. | Local disease progression during preoperative radiotherapy rendering disease no longer operable | During preoperative radiotherapy (for those patients that have preoperative radiotherapy) |
| 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. | 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. | 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. |
| 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. |
| OSU James Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Chris O'Brien Lifehouse | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Prince of Wales Hospital | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
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| UZ Leuven | Recruiting | Leuven | Flemish Brabant | 3000 | Belgium |
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| A.C.Camargo Cancer Center - Fundacao Antonio Prudente | Recruiting | Liberdade | São Paulo | 01509-010 | Brazil |
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| The Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| Institut Curie Hospital | Recruiting | Paris | 75005 | France |
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| The Netherlands Cancer Institute | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
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| ID | Term |
|---|---|
| C538370 | Retroperitoneal liposarcoma |
| D012509 | Sarcoma |
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018205 | Neoplasms, Adipose Tissue |
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