Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma
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.
Arms & interventions
Outcome measures
Primary
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
Time frame: Up to 5 years.
Secondary
Overall survival
Time frame: Up to 5 years.
Cumulative incidence of 2nd local recurrence (in a competing risk framework)
Time frame: Up to 5 years.
Cumulative incidence of distant metastases (in a competing risk framework).
Time frame: Up to 5 years.
Cumulative incidence of in-field relapse for those who had preoperative radiotherapy (in a competing risk framework)
Time frame: Up to 5 years.
Pathological response using the EORTC-STBSG criteria.
Time frame: At surgical resection.
Radiology response to preoperative RT.
Time frame: Within 4 weeks of surgery.
Local disease progression during preoperative radiotherapy.
Time frame: During preoperative radiotherapy (for those patients that have preoperative radiotherapy)
Distant disease progression during preoperative RT.
Time frame: During preoperative radiotherapy (for those patients that have preoperative radiotherapy).
Toxicity of preoperative radiotherapy
Time frame: From the start of preoperative radiotherapy up to one week prior to surgery
Surgical complication
Time frame: Up to 60 days post surgery
Health related quality of life using the EORTC QLQ-C30 and the EORTC QLQ-STO22 assessment scales.
Time frame: 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
Time frame: At surgery
Stratified analysis of use of chemotherapy
Time frame: Up to 5 years.
Validation of the recurrent RPS nomogram and the dynamic primary RPS nomogram
Time frame: Up to 5 years.
Eligibility criteria
Study locations (3)
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
OSU James Hospital
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030