High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma

NCT ID: NCT06480396

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 584 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2033-12-31

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).

Detailed Description

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). Both high and lower intensity follow-up represent current practice in different centres across the trial delivery network, with variation at a centre and surgeon level. SARveillance is co-produced in deep collaboration with a patient advisory group. The delivery network is trans-continental including major sarcoma centres in Europe, Asia, and the Americas with central coordination from Istituto Nazionale Tumori, Milan, Italy and Birmingham Centre for Observational and Prospective Studies (BiCOPS) University of Birmingham, UK. For centres that would otherwise be precluded from participating in SARveillance due to institutional level data sharing restrictions, provision has been made for prearranged Individual Participant Data Meta-Analysis (IPDMA). The IPDMA essentially replicates the instruments and processes of SARveillance at a single site level and allows for the PI to provide data for meta-analysis at the close of SARveillance, rather than sharing real-time data with the SARveillance servers at the coordinating institutions. Adult patients undergoing primary resection for retroperitoneal, abdominal and pelvic sarcoma will be eligible for inclusion. The trial design is innovative and efficient, implemented as a trial within an international registry, and adopting concepts from the pragmatic REaCT trial design methodology. Patients that are willing to be randomised will be allocated in a 1:1 ratio to a high or lower intensity follow-up schedule. For patients that decline randomisation, the trial has patient preference arms to maximise insight into decision-making processes in the context of a rare disease and maximise participant recruitment. The primary outcome measure is quality of life, measured as emotional functioning (EF) up to 5 years after surgery, measured 3-monthly, using the questions relating to the EF domain of the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30). Secondary outcomes for the trial will be overall survival up to 5 years after surgery, the cancer worry scale (EORTC library), health utility calculated using EuroQol Group EQ-5D-5L and cost-effectiveness health utility, measured using EQ-5D-5L. The primary outcome measure for low grade tumours is health utility. Pre-planned sub-studies will be conducted including an economic analysis, and validation study for a prognostic risk model.

Conditions

Sarcoma,Soft Tissue; Sarcoma Retroperitoneal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

High-intensity radiological surveillance

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)

Group Type: EXPERIMENTAL

High-intensity radiological surveillance

Intervention Type: 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

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)

Group Type: ACTIVE_COMPARATOR

Lower-intensity radiological surveillance

Intervention Type: 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.

Interventions

High-intensity radiological surveillance

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.

Intervention Type: DIAGNOSTIC_TEST

Lower-intensity radiological surveillance

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Birmingham

OTHER

Sponsor Role: collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University Hospital Padova

OTHER

Sponsor Role: collaborator

Campus Bio-Medico University

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Dana-Farber/Brigham and Women's Cancer Center

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role: collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Ford, PhD

Role: PRINCIPAL_INVESTIGATOR

samuel.ford@uhb.nhs.uk

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Countries

Italy; United Kingdom

Central Contacts

Marco Fiore, MD

Role: CONTACT

marco.fiore@istitutotumori.mi.it

022390 2910

Daniela Salvatore, PhD

Role: CONTACT

daniela.salvatore@istitutotumori.mi.it

022390 2796

Facility Contacts

Marco Fiore, MD

Role: primary

marco.fiore@istitutotumori.mi.it

022390 2910

Daniella Salvatore, PhD

Role: backup

daniela.salvatore@istitutotumori.mi.it

022390 2796

Marco Fiore, MD

Role: backup

Samuel Ford, PhD

Role: primary

samuel.ford@uhb.nhs.uk

+44 121 3715880

James Glasbey, PhD

Role: backup

j.glasbey@bham.ac.uk

+44 121 3715880

Samuel Ford, PhD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 35277304 (View on PubMed)

Related Links

https://tarpswg.org/wp-content/uploads/2020/07/8.sarveillance-tarpswg-meeting-july-2020.pdf

TARPSWG July 2020 - Trial development meeting

https://rcsed.shorthandstories.com/march-awards-grants/index.html

RCSEd Pump Priming Grant funding

Other Identifiers

INT201/16(05/23)

Identifier Type: -

Identifier Source: org_study_id