A New Fast DWI-based MR Protocol for Surveillance in Patients With a High Risk of Ovarian Cancer Recurrence During PARP-inhibitors Maintenance to Enhance Secondary Cytoreduction Results

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic resonance imaging as fpr clinical practice

    Other intervention

    An 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

Cytoreductive surgery rate

Optimal cytoreductive surgery rate

Time frame
36 months

Secondary outcomes

1

Concordance rate between MRI results and CA125 variations

Percentage of Concordance between MRI results and CA125 variations

Time frame
36 months
2

Concordance between MRI results and CT findings

Percentage of Concordance between MRI results and CT findings

Time frame
36 months
3

Rate of Survival

Progression-Free Survival and Overall Survival Rate

Time frame
36 months

Other outcomes

Sponsors and contacts

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