Sarcoma,Soft TissuePhase 3SARveillanceNCT06480396
High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma
A Phase 3 study testing High-intensity radiological surveillance and Lower-intensity radiological surveillance in people with Sarcoma,Soft Tissue and Sarcoma Retroperitoneal, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma,Soft Tissue, Sarcoma Retroperitoneal
- What is being tested?
- High-intensity radiological surveillance and Lower-intensity radiological surveillance
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2024to Dec 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Marco Fiore, MD, 022390 2910, marco.fiore@istitutotumori.mi.it
Daniella Salvatore, PhD, 022390 2796, daniela.salvatore@istitutotumori.mi.it
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2GW
Samuel Ford, PhD, +44 121 3715880, samuel.ford@uhb.nhs.uk
James Glasbey, PhD, +44 121 3715880, j.glasbey@bham.ac.uk
About this study
Official title: An International, 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 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).
Read the 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
- Being tested
- High-intensity radiological surveillance, Lower-intensity radiological surveillance
- Keywords
- Surveillance, Radiology, Surgery, Quality of life, Cost-effectiveness
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity radiological surveillanceDiagnostic 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 surveillanceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Diagnostic Test: Lower-intensity radiological surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
Overall survival
From time of primary surgery to death (all-cause mortality) or last follow up
Measured: 5 years
Cancer worry scale
Cancer-worry, assessed using four specific items from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life item library. Each of the four items 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.
Measured: 5 years
Health utility
EuroQol Group EQ-5D-5L. Each of the five items are scored between 1 and 5 (range: 4) to a total of 25 points, scaled to a weighted index between 0 and 1 using a validated formula from the EUROQOL scoring manual.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University Hospital Birmingham NHS Foundation Trust, Royal Marsden NHS Foundation Trust, University Hospital Padova, Campus Bio-Medico University, The Netherlands Cancer Institute, KU Leuven, Heidelberg University, Dana-Farber/Brigham and Women's Cancer Center, Emory University, Mayo Clinic, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, The Cleveland Clinic, M.D. Anderson Cancer Center, University of Southern California, Ohio State University, Ottawa Hospital Research Institute, McGill University, Peter MacCallum Cancer Centre, Australia, Royal Prince Alfred Hospital, Sydney, Australia
- Responsible party
- Sponsor
- Investigators
- Samuel Ford, PhD, Principal investigator, samuel.ford@uhb.nhs.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480396
- Sponsor's protocol ID
- INT201/16(05/23)
- Acronym
- SARveillance
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For international 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. As the IPDMA derived data is supported by identical trial processes and materials, the subsequent data submitted for meta-analysis will be comparable in quality, safeguarding the statistical integrity of SARveillance during the meta-analysis. Centres within the trial delivery network that utilise the IPDMA process will be internal sponsors for SARveillance at the institutional level and are required to complete a pre-emptive agreement to share unidentified data with the trial network coordinating institutions for meta-analysis when SARveillance closes.
Publications
Whitaker J, Nessim C, Almond M, Ford SJ. Surveillance Post Surgery for Retroperitoneal Soft Tissue Sarcoma. Curr Oncol. 2023 Feb 26;30(3):2781-2791. doi: 10.3390/curroncol30030211.
PubMed 36975424Baia 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.
PubMed 35277304