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

July 14, 2026 updated by: Australia and New Zealand Sarcoma Association
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Chris O'Brien Lifehouse
        • Principal Investigator:
          • Angela Hong
        • Contact:
      • Randwick, New South Wales, Australia, 2031
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • David Gyorki
  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Daphne Hompes
        • Contact:
  • Brazil
    • São Paulo
      • Liberdade, São Paulo, Brazil, 01509-010
        • Recruiting
        • A.C.Camargo Cancer Center - Fundacao Antonio Prudente
        • Contact:
        • Principal Investigator:
          • Samuel Aguiar Junior
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • The Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Charles Catton
  • France
      • Paris, France, 75005
        • Recruiting
        • Institut Curie Hospital
        • Contact:
        • Principal Investigator:
          • Dimitri Tzanis
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • The Netherlands Cancer Institute
        • Principal Investigator:
          • Rick Haas
        • Contact:
  • Poland
      • Warsaw, Poland, 00-001
        • Not yet recruiting
        • Maria Sklodowska-Curie National Research Institute of Oncology
        • Contact:
        • Principal Investigator:
          • Mateusz Spalek
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Winship Cancer Institute
        • Principal Investigator:
          • Kenneth Cardona
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Chandrajit Raut
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • OSU James Hospital
        • Contact:
        • Principal Investigator:
          • David Konieczkowski
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Christina Roland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with localized, resectable recurrent retroperitoneal liposarcoma attending and having treatment at the study site.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abdominopelvic recurrence-free survival (ARFS). .
Time Frame: 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
Up to 5 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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.
Up to 5 years.
Cumulative incidence of 2nd local recurrence (in a competing risk framework)
Time Frame: Up to 5 years.
Up to 5 years.
Cumulative incidence of distant metastases (in a competing risk framework).
Time Frame: Up to 5 years.
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.
Up to 5 years.
Pathological response using the EORTC-STBSG criteria.
Time Frame: At surgical resection.
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.
Time Frame: 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.
Within 4 weeks of surgery.
Local disease progression during preoperative radiotherapy.
Time Frame: During preoperative radiotherapy (for those patients that have 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.
Time Frame: During preoperative radiotherapy (for those patients that have preoperative radiotherapy).
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
From the start of preoperative radiotherapy up to one week prior to surgery
Surgical complication
Time Frame: Up to 60 days post surgery
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.
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
Time Frame: At surgery
At surgery
Stratified analysis of use of chemotherapy
Time Frame: Up to 5 years.
Up to 5 years.
Validation of the recurrent RPS nomogram and the dynamic primary RPS nomogram
Time Frame: Up to 5 years.
Up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Australia and New Zealand Sarcoma Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angela Hong, Chris O'Brien Lifehouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X23-0316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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