Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000554561
Ethics application status
Approved
Date submitted
18/04/2024
Date registered
1/05/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
1/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Study Evaluating The Treatment Outcomes For Localised Recurrent, Resectable Retroperitoneal Liposarcoma
Scientific title
Prospective Study Evaluating The Treatment Outcomes For Localised Recurrent, Resectable Retroperitoneal Liposarcoma in adults.
Secondary ID [1] 311988 0
X23-0316
Universal Trial Number (UTN)
Trial acronym
ReLaPSe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retroperitoneal Liposarcoma (LPS) 333603 0
Condition category
Condition code
Cancer 330287 330287 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Group 1: Surgery with preoperative radiotherapy (RT) (can include any chemotherapy).

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 QLQ-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.

Intervention code [1] 328448 0
Not applicable
Comparator / control treatment
Group 2: Surgery without preoperative radiotherapy (can include surgery alone, surgery with postoperative radiotherapy and/or any chemotherapy).
Control group
Active

Outcomes
Primary outcome [1] 338028 0
Abdominopelvic recurrence-free survival (ARFS). Liver metastases will be regarded as distant metastatic events, rather than abdominopelvic relapse.
Timepoint [1] 338028 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [1] 434194 0
Toxicity of preoperative RT.
Timepoint [1] 434194 0
This will be recorded weekly during the course of RT as per standard of care, and one week prior to surgery
Secondary outcome [2] 434180 0
Cumulative incidence of in-field relapse for those who had preoperative RT
Timepoint [2] 434180 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [3] 434176 0
Overall survival Causes of death will be recorded.
Timepoint [3] 434176 0
Every 3-6 months post treatment follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [4] 434196 0
Patient reported quality of life assessment
Timepoint [4] 434196 0
At registration, during the last week of RT treatment (preoperative RT patients only), within 2 weeks prior to surgery (for the preoperative RT patients), 3 months and 12 months post-surgery
Secondary outcome [5] 434178 0
Cumulative incidence of 2nd local recurrence
Timepoint [5] 434178 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [6] 434183 0
Local disease progression rendering disease no longer operable.
Timepoint [6] 434183 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [7] 434182 0
Radiology response to preoperative RT.
Timepoint [7] 434182 0
At baseline and after preoperative radiotherapy (within 2 weeks of surgery)
Secondary outcome [8] 434181 0
Pathological response
Timepoint [8] 434181 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [9] 434179 0
Cumulative incidence of distant metastases
Timepoint [9] 434179 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.
Secondary outcome [10] 434195 0
Surgical complication
Timepoint [10] 434195 0
At each visit post-surgery up to 60 days post-surgery
Secondary outcome [11] 434193 0
Distant disease progression during preoperative RT
Timepoint [11] 434193 0
Post-treatment and at every 3-6 month follow up visit (according to institutional guidelines) for a total of 5 years.

Eligibility
Key inclusion criteria
1. Aged 18 years or older 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 ethics approved written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/05/2024
Actual
Date of last participant enrolment
Anticipated
27/05/2027
Actual
Date of last data collection
Anticipated
27/05/2032
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 27083 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 43153 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 26252 0
Netherlands
State/province [1] 26252 0

Funding & Sponsors
Funding source category [1] 316336 0
Hospital
Name [1] 316336 0
Royal Prince Alfred Hospital
Country [1] 316336 0
Australia
Funding source category [2] 316389 0
Other Collaborative groups
Name [2] 316389 0
Australia and New Zealand Sarcoma Association
Country [2] 316389 0
Australia
Funding source category [3] 316387 0
Hospital
Name [3] 316387 0
Peter MacCallum Cancer Centre
Country [3] 316387 0
Australia
Funding source category [4] 316388 0
Hospital
Name [4] 316388 0
Prince of Wales Hospital
Country [4] 316388 0
Australia
Funding source category [5] 316392 0
Hospital
Name [5] 316392 0
Chris O'Brien Lifehouse
Country [5] 316392 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia and New Zealand Sarcoma Association
Address
Country
Australia
Secondary sponsor category [1] 318519 0
None
Name [1] 318519 0
Address [1] 318519 0
Country [1] 318519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315146 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315146 0
Ethics committee country [1] 315146 0
Australia
Date submitted for ethics approval [1] 315146 0
Approval date [1] 315146 0
17/10/2023
Ethics approval number [1] 315146 0
2023/ETH01899

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133814 0
Prof Angela Hong
Address 133814 0
Royal Prince Alfred Hospital. 50 Missenden Rd, Camperdown NSW 2050
Country 133814 0
Australia
Phone 133814 0
+61 418388875
Fax 133814 0
Email 133814 0
angela.hong@sydney.edu.au
Contact person for public queries
Name 133815 0
Janina Chapman
Address 133815 0
Australia and New Zealand Sarcoma Association. 305 Grattan Street, Melbourne VIC 3000
Country 133815 0
Australia
Phone 133815 0
+61 414316490
Fax 133815 0
Email 133815 0
janina.chapman@petermac.org
Contact person for scientific queries
Name 133816 0
Angela Hong
Address 133816 0
Chris O'Brien Lifehouse. 119-143 Missenden Rd, Camperdown NSW 2050
Country 133816 0
Australia
Phone 133816 0
+61 418388875
Fax 133816 0
Email 133816 0
angela.hong@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.