Clinical trial NCT06480396: High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Sarcoma,Soft Tissue
Sarcoma Retroperitoneal
Keywords: Surveillance
Radiology
Surgery
Quality of life
Cost-effectiveness
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: University Hospital Birmingham NHS Foundation Trust
name: Royal Marsden NHS Foundation Trust
name: University Hospital Padova
name: Campus Bio-Medico University
name: The Netherlands Cancer Institute
name: KU Leuven
name: Heidelberg University
name: Dana-Farber/Brigham and Women's Cancer Center
name: Emory University
name: Mayo Clinic
name: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: The Cleveland Clinic
name: M.D. Anderson Cancer Center
name: University of Southern California
name: Ohio State University
name: Ottawa Hospital Research Institute
name: McGill University
name: Peter MacCallum Cancer Centre, Australia
name: Royal Prince Alfred Hospital, Sydney, Australia
First posted: 2024-06-28
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Emotional Functioning
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Cancer worry scale
timeFrame: 5 years
measure: Health utility
timeFrame: 5 years
Other outcomes:
measure: Disease free survival
timeFrame: 5 years
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: samuel.ford@uhb.nhs.uk
name: Samuel Ford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.