High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma

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).

Conditions

• Sarcoma,Soft Tissue
• Sarcoma Retroperitoneal

Interventions

DIAGNOSTIC_TEST

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.

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.

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Royal Marsden NHS Foundation Trust

  collaborator OTHER

• University Hospital Padova

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Dana-Farber/Brigham and Women's Cancer Center

  collaborator OTHER

• Emory University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• McGill University

  collaborator OTHER

• Peter MacCallum Cancer Centre, Australia

  collaborator OTHER

• Royal Prince Alfred Hospital, Sydney, Australia

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Samuel Ford, PhD · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-30

Primary Completion

2033-12-31

Completion

2033-12-31

Countries

• Italy
• United Kingdom

Study Locations