Retroperitoneal LiposarcomaReLaPSeNCT07377747
Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma
An observational study of Retroperitoneal Liposarcoma, run by Australia and New Zealand Sarcoma Association at 13 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Liposarcoma
- How many people
- 100 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 5 Sep 2024to Dec 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with localized, resectable recurrent retroperitoneal liposarcoma attending and having treatment at the study site.
Who may be able to join
- 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)
- 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
- Previous histologically proven well-differentiated or dedifferentiated liposarcoma histology only
- Sarcoma not originating from bone or abdominal or gynecological viscera
- 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)
- WHO performance status 0-2
Show all 13Show fewer
- American Society of Anaesthesiologist (ASA) score 1-3
- No prior RT for the retroperitoneal liposarcoma
- Prior systemic therapy is allowed
- No concurrent active malignancy (except for low risk skin malignancy, low risk prostate carcinoma, low risk breast carcinoma including in situ disease)
- Women of childbearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
- Patient deemed able to comply with study requirements according to investigator evaluation
- Signed, IRB-approved written informed consent
Who cannot join
- Unresectable disease or likely R2 resection as assessed by the multidisciplinary sarcoma team
- Extent of recurrence where preoperative RT to all visible disease is not deemed to be feasible
- Contradiction for RT such as history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
- Myxoid liposarcoma histology
- Pregnancy
Trial locations and contacts
13 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 8 countries
United States4 sites, 4 recruiting
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Jennifer Glass, 404-778-1900, jennifer.glass@emoryhealthcare.org
Kenneth Cardona
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kodey Silknitter, 617-732-5500, ksilknitter@bwh.harvard.edu
Chandrajit Raut
- Recruiting
OSU James Hospital
Columbus, Ohio, 43210
David Konieczkowski, 614-293--3300, david.konieczkowski@osumc.edu
David Konieczkowski
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Amalia Gonzalez, 877-632-6789, argonzalez@mdanderson.org
Christina Roland
Australia3 sites, 3 recruiting
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Angela Hong, 61285140000, angela.hong@sydney.edu.au
Angela Hong
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Averil Liddicoat, 61385595000, surgicalresearchteam@petermac.org
David Gyorki
- Recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Diana Nawara, 61293822222, seslhd-sarcomadatamanager@health.nsw.gov.au
Yeh Chen Lee
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Flemish Brabant, 3000
Lieve Bruggeman, 32 16347195, lieve.bruggeman@uzleuven.be
Daphne Hompes
Brazil1 site, 1 recruiting
- Recruiting
A.C.Camargo Cancer Center - Fundacao Antonio Prudente
Liberdade, São Paulo, 01509-010
Bruna E Catin Kupper, 112189-5010 ext. 2832, bruna.catin@accamargo.org.br
Samuel Aguiar Junior
Canada1 site, 1 recruiting
- Recruiting
The Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Charles Catton, 416-946-4558, charles.catton@uhn.ca
Charles Catton
France1 site, 1 recruiting
- Recruiting
Institut Curie Hospital
Paris, 75005
Lynda Corvi, +33 1 56 24 55 00, lynda.corvi@curie.fr
Dimitri Tzanis
Netherlands1 site, 1 recruiting
- Recruiting
The Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
Lisa van den Hengel, 31643291801, l.vd.hengel@nki.nl
Rick Haas
Poland1 site, 1 recruiting
- Not yet recruiting
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 00-001
Mateusz Spalek, +48 22 546 24 55, mateusz.spalek@nio.gov.pl
Mateusz Spalek
About this study
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.
Read the 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.
- Conditions
- Retroperitoneal Liposarcoma
- Keywords
- Sarcoma, liposarcoma, retroperitoneal
- Medical subject headings
- Retroperitoneal liposarcoma, Sarcoma, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 5 years.
Secondary outcomes (14)
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.
Measured: Up to 5 years.
Cumulative incidence of 2nd local recurrence (in a competing risk framework)
Measured: Up to 5 years.
Cumulative incidence of distant metastases (in a competing risk framework).
Measured: Up to 5 years.
Cumulative incidence of in-field relapse for those who had preoperative radiotherapy (in a competing risk framework)
Measured: 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.
Measured: 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.
Measured: Within 4 weeks of surgery.
Local disease progression during preoperative radiotherapy.
Local disease progression during preoperative radiotherapy rendering disease no longer operable
Measured: During preoperative radiotherapy (for those patients that have preoperative radiotherapy)
Distant disease progression during preoperative RT.
Measured: During preoperative radiotherapy (for those patients that have preoperative radiotherapy).
Toxicity of preoperative radiotherapy
Measured: From the start of preoperative radiotherapy up to one week prior to surgery
Surgical complication
Measured: 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.
Measured: 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
Measured: At surgery
Stratified analysis of use of chemotherapy
Measured: Up to 5 years.
Validation of the recurrent RPS nomogram and the dynamic primary RPS nomogram
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Sep 2024
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal LiposarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australia and New Zealand Sarcoma Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Hong, Principal investigator, Chris O'Brien Lifehouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377747
- Sponsor's protocol ID
- X23-0316
- Acronym
- ReLaPSe
- Status last verified
- Jul 2026
- First submitted
- 4 Jan 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No