Trial Title:
High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma
NCT ID:
NCT06480396
Condition:
Sarcoma,Soft Tissue
Sarcoma Retroperitoneal
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
Surveillance
Radiology
Surgery
Quality of life
Cost-effectiveness
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
High-intensity radiological surveillance
Description:
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.
Arm group label:
High-intensity radiological surveillance
Intervention type:
Diagnostic Test
Intervention name:
Lower-intensity radiological surveillance
Description:
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.
Arm group label:
Lower-intensity radiological surveillance
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milan
Zip:
20133
Country:
Italy
Contact:
Last name:
Marco Fiore, MD
Phone:
022390 2910
Email:
marco.fiore@istitutotumori.mi.it
Contact backup:
Last name:
Daniella Salvatore, PhD
Phone:
022390 2796
Email:
daniela.salvatore@istitutotumori.mi.it
Contact backup:
Last name:
Marco Fiore, MD
Facility:
Name:
University Hospitals Birmingham NHS Foundation Trust
Address:
City:
Birmingham
Zip:
B15 2GW
Country:
United Kingdom
Contact:
Last name:
Samuel Ford, PhD
Phone:
+44 121 3715880
Email:
samuel.ford@uhb.nhs.uk
Contact backup:
Last name:
James Glasbey, PhD
Phone:
+44 121 3715880
Email:
j.glasbey@bham.ac.uk
Contact backup:
Last name:
Samuel Ford, PhD
Start date:
November 2024
Completion date:
December 2033
Lead sponsor:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Collaborator:
Agency:
University of Birmingham
Agency class:
Other
Collaborator:
Agency:
University Hospital Birmingham NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University Hospital Padova
Agency class:
Other
Collaborator:
Agency:
Campus Bio-Medico University
Agency class:
Other
Collaborator:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
KU Leuven
Agency class:
Other
Collaborator:
Agency:
Heidelberg University
Agency class:
Other
Collaborator:
Agency:
Dana-Farber/Brigham and Women's Cancer Center
Agency class:
Other
Collaborator:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Agency class:
Other
Collaborator:
Agency:
The Cleveland Clinic
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
Ohio State University
Agency class:
Other
Collaborator:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Collaborator:
Agency:
McGill University
Agency class:
Other
Collaborator:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Collaborator:
Agency:
Royal Prince Alfred Hospital, Sydney, Australia
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06480396
https://tarpswg.org/wp-content/uploads/2020/07/8.sarveillance-tarpswg-meeting-july-2020.pdf
https://rcsed.shorthandstories.com/march-awards-grants/index.html
