Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07377747

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Retroperitoneal Liposarcoma Liposarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Cumulative incidence of 2nd local recurrence (in a competing risk framework)

    Time frame: Up to 5 years.

  3. Cumulative incidence of distant metastases (in a competing risk framework).

    Time frame: Up to 5 years.

  4. Cumulative incidence of in-field relapse for those who had preoperative radiotherapy (in a competing risk framework)

    Time frame: Up to 5 years.

  5. 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.

  6. 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.

  7. 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

  8. Distant disease progression during preoperative RT.

    Time frame: During preoperative radiotherapy (for those patients that have preoperative radiotherapy).

  9. Toxicity of preoperative radiotherapy

    Time frame: From the start of preoperative radiotherapy up to one week prior to surgery

  10. Surgical complication

    Time frame: Up to 60 days post surgery

  11. 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.

  12. Unplanned R2 resection

    Time frame: At surgery

  13. Stratified analysis of use of chemotherapy

    Time frame: Up to 5 years.

  14. Validation of the recurrent RPS nomogram and the dynamic primary RPS nomogram

    Time frame: Up to 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Janina Chapman

CONTACT

[email protected]

61414316490

Sponsors and collaborators

Lead sponsor

Australia and New Zealand Sarcoma Association

Other

Registry information

Acronym: ReLaPSe

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Jan 30, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.