Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma

Australia and New Zealand Sarcoma Association100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Retroperitoneal Liposarcoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Emory Winship Cancer Institute

Atlanta, Georgia, United States

RECRUITING

OSU James Hospital

Columbus, Ohio, United States

NOT_YET_RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

RECRUITING

UZ Leuven

Leuven, Flemish Brabant, Belgium

RECRUITING

A.C.Camargo Cancer Center - Fundacao Antonio Prudente

Liberdade, São Paulo, Brazil

RECRUITING

The Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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.

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.

Obtained by using the standardised pathological evaluation score for assessing tumour response as recorded in the patient's medical records.

Time frame: 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.

Time frame: Within 4 weeks of surgery.

Local disease progression during preoperative radiotherapy.

Local disease progression during preoperative radiotherapy rendering disease no longer operable

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.

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.

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.

Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma

Overview

Conditions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts