About this trial
In ovarian cancer (OC), complete surgical debulking and platinum-based chemotherapy are the standard treatment, now followed by maintenance therapy with PARP inhibitors or Bevacizumab. However, in advanced-stage ovarian cancer, recurrence is common, with a progression-free survival of about 16 months. Secondary cytoreductive surgery (SCS) at the time of recurrence prolongs the overall survival and gives the possibility to extend the use of PARP-i. SCS is possible only when recurrence has limited extension. However, in OC, there is no well-established and widely accepted scheme for surveillance during maintenance therapy; ESMO guidelines suggest physical examination for the follow-up and allow ultrasound, CT, PET-CT and MRI to confirm the recurrence and plan surgical treatment if appropriate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with BRCA wild-type, HRP, high-grade serous ovarian cancer
No residual tumour at first debulking surgery
More than 6 months since the last platinum-based therapy
Disqualifiers
Patients who will not consent to participate in the study
Trial population
Patients with a diagnosis of HGSOC with BRCA wild-type, without residual tumour after first debulking surgery, who are planned for CT/MRI exams as for Follow Up Clinical Practice, after more than 6 months since the last platinum-based therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Magnetic resonance imaging as fpr clinical practice
Other interventionAn abbreviated MR protocol of the abdomen will be used inh association with CT scan; it does not need contrast injection and does not add any risk for patients.
Treatment groups
Trial outcomes
Primary outcomes
Cytoreductive surgery rate
Optimal cytoreductive surgery rate
Secondary outcomes
Concordance rate between MRI results and CA125 variations
Percentage of Concordance between MRI results and CA125 variations
Concordance between MRI results and CT findings
Percentage of Concordance between MRI results and CT findings
Rate of Survival
Progression-Free Survival and Overall Survival Rate
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: