High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma

NCT06480396 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: INT201/16(05/23)
• Study Type: interventional
• Target: 584
• Locations: 2 countries
• Sites: 2

Brief Summary

The SARveillance trial is an efficient, pragmatic, multi-centre, international, stratified, partially-randomised, patient-preference trial within a registry of high versus lower intensity radiological surveillance following primary resection of retroperitoneal, abdominal and pelvic soft tissue sarcoma. The trial design is stratified by sarcoma tumour grade (high/intermediate grade and low grade).

Conditions

Sarcoma,Soft Tissue; Sarcoma Retroperitoneal

Keywords

Surveillance; Radiology; Surgery; Quality of life; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Emotional Functioning

  Quality of life, assessed using Emotional Functioning domain (items 21-24) of the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30). Each of the four items for this functional domain are scored between 1 and 4 (range: 3) to a total of 16 points, scaled to a total out of 100 using a validated formula from the EORTC scoring manual.

  5 years

Secondary Outcomes (3)

• Overall survival

  5 years

• Cancer worry scale

  5 years

• Health utility

  5 years

Other Outcomes (1)

• Disease free survival

  5 years

Study Arms (2)

High-intensity radiological surveillance

EXPERIMENTAL

High/intermediate grade histology: 3-4 monthly CT scan up to 2-years postoperatively, 6-monthly CT scan from 2-5 years postoperatively (schedule 1) Low grade histology: 6-monthly CT scan up to 2-years postoperatively, annual CT scan from 2-5 years postoperatively (schedule 2)

Diagnostic Test: High-intensity radiological surveillance

Lower-intensity radiological surveillance

ACTIVE COMPARATOR

High intermediate grade histology: 6-monthly CT scan up to 2-years postoperatively, annual CT scan from 2-5 years postoperatively (schedule 2) Low grade histology: Annual CT scan up to 2-years postoperatively, 18 monthly CT scan from 2-5 years postoperatively (schedule 3)

Diagnostic Test: Lower-intensity radiological surveillance

Interventions

High-intensity radiological surveillance DIAGNOSTIC_TEST

The standard approach to surveillance imaging will be contrasted CT (IV and oral contrast) of the chest, abdomen and pelvis. All patients require radiological assessment of the chest, abdomen and pelvis at each surveillance round. Tolerance will be given in the protocol for selected patients where CT is not suitable to receive alternative imaging such as MRI or combination of MRI and CT. Uncontrasted CT imaging is permissible where renal toxicity or allergy from intravenous contrast is of concern. The use of plain radiography is not permitted as an alternative to CT imaging of the chest.

High-intensity radiological surveillance

Lower-intensity radiological surveillance DIAGNOSTIC_TEST

The standard approach to surveillance imaging will be contrasted CT (IV and oral contrast) of the chest, abdomen and pelvis. All patients require radiological assessment of the chest, abdomen and pelvis at each surveillance round. Tolerance will be given in the protocol for selected patients where CT is not suitable to receive alternative imaging such as MRI or combination of MRI and CT. Uncontrasted CT imaging is permissible where renal toxicity or allergy from intravenous contrast is of concern. The use of plain radiography is not permitted as an alternative to CT imaging of the chest.

Lower-intensity radiological surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (greater than 18 years)
• Primary resection
• Histologically confirmed retroperitoneal, abdominal or pelvic soft tissue sarcoma
• R0/R1 resection
• Eligible whether or not the participant undergoes neoadjuvant treatment

You may not qualify if:

• Metastatic disease at time of randomisation
• Recurrent, metastatic or residual disease identified on baseline CT imaging (3-4 months post primary resection)
• Reoperation for recurrent soft tissue sarcoma
• Re-resection following previous inadequate surgery
• R2 resection
• Patients receiving adjuvant therapy that will delay, interrupt or render radiological surveillance unpredictable
• Uterine sarcomas, gastrointestinal stromal tumour (GIST), fibromatosis, epithelial tumours, multifocal disease, sarcomas of bony origin
• Patient declined to consent to data sharing with RESAR (unless in a centre contributing via pre-planned IPDMA)

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• University of Birmingham: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• University Hospital Padova: collaborator
• Campus Bio-Medico University: collaborator
• The Netherlands Cancer Institute: collaborator
• KU Leuven: collaborator
• Heidelberg University: collaborator
• Dana-Farber/Brigham and Women's Cancer Center: collaborator
• Emory University: collaborator
• Mayo Clinic: collaborator
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium: collaborator
• The Cleveland Clinic: collaborator
• M.D. Anderson Cancer Center: collaborator
• University of Southern California: collaborator
• Ohio State University: collaborator
• Ottawa Hospital Research Institute: collaborator
• McGill University: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• Royal Prince Alfred Hospital, Sydney, Australia: collaborator

Study Sites (2)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2GW, United Kingdom

Location

Related Publications (1)

• Baia M, Ford SJ, Dumitra S, Sama L, Naumann DN, Spolverato G, Callegaro D. Follow-up of patients with retroperitoneal sarcoma. Eur J Surg Oncol. 2023 Jun;49(6):1125-1132. doi: 10.1016/j.ejso.2022.02.016. Epub 2022 Mar 4.

  PMID: 35277304 BACKGROUND

Related Links

• TARPSWG July 2020 - Trial development meeting
• RCSEd Pump Priming Grant funding

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Samuel Ford, PhD

  samuel.ford@uhb.nhs.uk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Fiore, MD

CONTACT

022390 2910; marco.fiore@istitutotumori.mi.it

Daniela Salvatore, PhD

CONTACT

022390 2796; daniela.salvatore@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients that are willing to be randomised will be allocated in a 1:1 ratio to a high or lower intensity follow-up schedule. The trial design is partially randomised controlled and partly patient choice with patient preference arms (PPAs) for those that decline randomisation. Patients fulfilling the inclusion criteria and willing to be recruited will be stratified by tumour grade and then randomised to either high or lower intensity surveillance. Patients who decline randomisation will subsequently be offered the opportunity to participate within the PPAs. The PPAs will allow participating patients to choose either high or lower intensity surveillance arms. The data generated from the PPAs will not be included in the comparison of randomised arms. However, they will give important insight into patients' motivations in choosing high or lower intensity surveillance.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: October 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon locking the study database upon completion of last patient's follow-up.
• Access Criteria: After approval by the central Trial Management group and completion of a study data sharing agreement.

Locations

IT (1); GB (1)