Clinical Trial Details
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Phase N/AInterventional
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
Protocol: STUDY00008451NCT: NCT06480396
Overview
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
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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)
