Clinical trial · Interventional
Impact of Systematic Imaging for Follow up of Patients With Ovarian, Fallopian Tube or Primary Peritoneum Cancer
Randomized Study Evaluating the Impact on the Cost and Quality of Life of Follow up by Systematic Imaging in Patients With Advanced Stage Ovarian, Fallopian Tube or Primary Peritoneum Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No longer feasible because of new recommendations (RPC St Paul de Vence) which advocate the performance of systematic imaging in addition to CA 125 in patients treated in first line maintenance in order not to ignore a relapse (2021).
Summary
Brief summary (as posted)
After well-conducted treatment of ovarian, tubal and primary peritoneum cancer by maximum tumor reduction surgery and chemotherapy including platinum salt and paclitaxel, the clinical remission rate is over 50%. However, 75-80% of patients with ovarian, tube or primary peritoneum cancer recur within 2 years of the end of treatment. In the latest INCa recommendations for 2018, systematic imaging (thoraco-abdomino-pelvic scanner (CT), MRI, PET CT) is not recommended based on the literature because of its low added value compared to CA 125 dosage (sensitivity ranging from 67% to 95%, and specificity of 87% to 93%), its irradiating character (CT) and its cost. However, the recommendations are based on imaging studies dating back at least a decade. Since these studies, technological advances have improved the diagnostic performance of imaging: sensitivity is 78% for whole-body CT scans and 98% for full-body MRI for the diagnosis of ovarian cancer recurrence. Furthermore, previous randomized studies showed no survival benefit with early treatment of relapse on the basis of a high concentration of CA125 alone, so the value of routine CA125 measurement in the follow-up of ovarian cancer patients may be limited. These recent studies lead to heterogeneity in surveillance protocols for ovarian cancer patients despite recommendations. In addition, treatments for recurrences have evolved as well as maintenance treatments to become chronic treatments, with the emergence of the maintenance new treatments detecting early recurrence is particularly important (notably through the development of new molecules given in maintenance treatment). But early detection have to be balanced with the quality of life of these patients. In usual care, imaging surveillance is often carried out despite the absence of recommendations or data from the literature of high level of evidence. The question arises as to whether radiological monitoring could make an impact on patient survival without being a source of excessive false positives, patient stress and non-productive costs. QUALOV trial is a multicenter randomized study for patients in remission after treatment of advanced stage serous epithelial ovarian, fallopian tube or primary peritoneum cancer (stage III and beyond). The main objective is to assess the effectiveness of systematic imaging for patients followed after advanced stage serous epithelial ovarian, fallopian tube or primary peritoneum cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Stage Cancer of Peritoneum | — | UNRESOLVED | — |
| Advanced Stage Cancer of Tubes | — | UNRESOLVED | — |
| Advanced Stage Serous Epithelial Cancer of the Ovary | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follow-up strategy | Other | — | UNRESOLVED |
| Standard strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard arm
- interventionNames
- Other: Standard strategy
- type
- EXPERIMENTAL
- label
- Interventional arm
- interventionNames
- Other: Follow-up strategy
Primary outcomes (1)
- measure
- 24-month incremental cost-to-utility ratio
- timeFrame
- At 24 months after inclusion
- description
- Incremental cost-utility ratio defined as the difference in total cost at 2 years between the systematic imaging strategy and the standard strategy, relative to the difference in survival and quality of life (QALYs).
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged at least 18 years. * Patients in remission from proven stage III and above serous epithelial cancer of the ovary, peritoneum or tubes with complete macroscopic surgical resection (whether initial or interval) * Signature of informed consent by the patient * Affiliation to a French social security scheme (excluding AME) Exclusion Criteria: * Patients with a contraindication to MRI or CT examination (wearing a material with magnetic properties : pacemaker, ferromagnetic material, etc.) * Intolerance to iodinated contrast or gadolinium or severe renal failure (DFG \<30 ml/min/1.73 m2) * Patients deprived of their liberty and patients Under legal protection (under guardianship or under curatorship) * Patients participating in another interventional research (in particular research with radiological exposure as well
References
Publications (0)
Data not yet available