NCT06480396Not yet recruitingPhase 3
High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 584 (estimated)
- First submitted
- 24 Jun 2024
- Start date
- Nov 2024
- Primary completion date
- Dec 2033
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Sarcoma
- NCT number
- NCT06480396
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 584
- From Nov 2024 to the primary completion date, Dec 2033
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Re-resection following previous inadequate surgery
- R2 resection
- Patients receiving adjuvant therapy that will delay, interrupt or render radiological surveillance unpredictable
Other illness
- Metastatic disease at time of randomisation
- Recurrent, metastatic or residual disease identified on baseline CT imaging (3-4 months post primary resection)
- Uterine sarcomas, gastrointestinal stromal tumour (GIST), fibromatosis, epithelial tumours, multifocal disease, sarcomas of bony origin
Other
- Reoperation for recurrent soft tissue sarcoma
- Patient declined to consent to data sharing with RESAR (unless in a centre contributing via pre-planned IPDMA)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.