High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma

ConditionsSarcoma,Soft Tissue Sarcoma Retroperitoneal

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (greater than 18 years)

Primary resection

Histologically confirmed retroperitoneal, abdominal or pelvic soft tissue sarcoma

R0/R1 resection

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

High-intensity radiological surveillance
Diagnostic 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 surveillance
Diagnostic 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.

Treatment groups

584 Participants

are divided into 2 treatment groups

Group A: High-intensity radiological surveillanceExperimental treatment 1 intervention

Group B: Lower-intensity radiological surveillanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

5 years

Secondary outcomes

Overall survival

From time of primary surgery to death (all-cause mortality) or last follow up

Time frame

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.

Time frame

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.

Time frame

5 years

Other outcomes

Disease free survival

Defined as time from primary surgery to radiological evidence of disease recurrence as defined by the revised-RECIST criteria, by definition will be decreased in the high intensity follow-up group. This will be adopted as a process measure rather than an outcome measure.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

University of Birmingham

Collaborator

University Hospital Birmingham NHS Foundation Trust

Collaborator

Royal Marsden NHS Foundation Trust

Collaborator

University Hospital Padova

Collaborator

Campus Bio-Medico University

Collaborator

The Netherlands Cancer Institute

Collaborator

KU Leuven

Collaborator

Heidelberg University

Collaborator

Dana-Farber/Brigham and Women's Cancer Center

Collaborator

Emory University

Collaborator

Mayo Clinic

Collaborator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Collaborator

The Cleveland Clinic

Collaborator

M.D. Anderson Cancer Center

Collaborator

University of Southern California

Collaborator

Ohio State University

Collaborator

Ottawa Hospital Research Institute

Collaborator

McGill University

Collaborator

Peter MacCallum Cancer Centre, Australia

Collaborator

Royal Prince Alfred Hospital, Sydney, Australia

Collaborator

Source ClinicalTrials.gov

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