Advanced Stage Cancer of Peritoneum Clinical Trial
— QUALOVOfficial title:
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
| Verified date | December 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 22, 2021 |
| Est. primary completion date | June 22, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Pitié Salpêtrière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 24-month incremental cost-to-utility ratio | 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). | At 24 months after inclusion | |
| Secondary | Duration without treatment | Duration without treatment is defined as the time between randomization at the end of the initial treatment and initiation of the following treatment (surgery or chimiotherapy) | At 24 months after randomization | |
| Secondary | Mean score of HAD (Hospital Anxiety and Depression scale) | Hospital Anxiety and Depression scale will be used | at 3 months, 6 months, 12 months, 18 months and 24 months after randomization | |
| Secondary | Mean score of Quality of Life | Quality of life of patients will be measured using the EQ5D questionnaire | at 3 months, 6 months, 12 months, 18 months and 24 months after randomization | |
| Secondary | Overall survival | Overall survival is defined as the time from the date of randomization to death regardless of the cause of death. | At 24 months after randomization | |
| Secondary | Tumor board's decision to treat the patient for recurrence | Tumor board decision elements (CA125 elevation alone, CA125 elevation and suspicious imaging, normal but normal CA125 mass detection, modification of several biological dosages, change in suspicious volume to imaging,...) will be collected and linked to | At 24 months after randomization | |
| Secondary | Rate of complete secondary surgery | To predict the possibility of complete resection of recurrence by surgery | At 24 months after inclusion | |
| Secondary | Rate of surgery for recurrence | To compare the percentage of operable patients in each group | At 24 months after inclusion | |
| Secondary | Change in caregiver preference on ideal monitoring modalities | Caregiver preference questions on ideal monitoring modalities : - "How important is imaging to you in the monitoring of ovarian, tube and primary peritoneal cancers" rated on a scale of 0 to 4. |
at randomization and at 24 month after the last patient randomization (end of the study) | |
| Secondary | Patient preference on ideal monitoring modalities for patient of interventional group | Patient preference questions on ideal monitoring modalities : - "Do you think the constraints of routine follow-up imaging are acceptable for a situation like yours? " rated on a scale of 0 to 4. |
at 24 month after randomization | |
| Secondary | Diagnostic performance of HE4 | Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value) of CA125 and CA125-HE4 will be estimated on the subgroup of patients who had both dosages during their follow-up. | At 24 months after inclusion | |
| Secondary | Cost/life-year gained over lifetime horizon | Survival measured by the area between the two Kaplan Meier curves, costs are in euros | 2 years | |
| Secondary | Number of subjects to be screened to gain one | Number of subjects to be screened to gain one | 2 years | |
| Secondary | Incremental cost-to-utility ratio | Incremental cost-utility ratio defined as the difference in total cost between the systematic imaging strategy and the standard strategy, relative to the difference in survival and quality of life (QALYs). | 2 years | |
| Secondary | Budgetary impact at 5 years | Costs in euros | At 5 years | |
| Secondary | Cost/complete resection of recurrent disease | Cost/complete resection of recurrent disease | At 24 months |