High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma

NCT06480396 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Phase

Phase 3

Started

2024-11

Last updated

2024-10-16

Condition(s) studied

Sarcoma,Soft TissueSarcoma Retroperitoneal

Investigational drug(s) / intervention(s)

High-intensity radiological surveillanceLower-intensity radiological surveillance

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.

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Emotional Functioning — 5 years
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.

Trial sites (2)

Facility	City	Region	Status
Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Lombardy
University Hospitals Birmingham NHS Foundation Trust	Birmingham	West Midlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06480396 on ClinicalTrials.gov ↗ ← All trials in Italy