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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- 24-month incremental cost-to-utility ratio
Study Overview
Brief Summary
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
Detailed Description
This is a randomized multi-center study. Randomization will be stratified on two major prognostic factors:
- The BRCA mutation (germline or somatic)
- the serous high or low grade histological subtype of histological se topical (defined according to morphological-well-differentiated criteria, low to moderate atypia, <3-4 mitoses/10 fields-and immunohistochemical-RO - strong p16/p53 low) At J0, after obtaining informed consent or within 7 days, patients will be randomized in one of the two arms (intervention group/standard group).
In the intervention arm, patients will perform a ca125 dosing ,/he4 dosage, a thoraco abdomino pelvic CT scan after contrast product injection and a full-body MRI (T2, DW and T1 sequences after fat saturation before and after gadolinium injection) with a maximum of 15 days between the two examinations, and will complete the HAD and EQ5D self-tests. A senior radiologist from each center will perform a prospective reading of each of the imaging. For any suspicious anomaly identified, the following criteria will be analyzed: Size, location, number, scalability, contrast taking after injection, MRI signal (T2, Diffusion, Dynamic Enhancement Curve). The RECIST criteria (version 1.1) will be applied.
In the standard arm, patients will perform a dosage of CA 125 (HE4 dosage), complete the HAD and EQ5D self-questionnaires, and the patient will be managed according to the INCa 2018 recommendations.
In the case of clinical abnormality (symptoms such as pain, transit changes, increased abdominal volume; or abnormality in clinical examination such as palpation of a mass, carcinosis nodule or suspicious adenopathy), marker elevation (CA125 >2N and/or 70 IU/L, HE4 > 140 pmol/L) and/or imaging (read by a senior at the center), the patient will be referred to the Multidisciplinary Consultation Meeting (PCR) for management according to the INCa 2018 recommendations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard arm
Intervention: Standard strategy (Other)
Interventional arm
Intervention: Follow-up strategy (Other)
Outcomes
Primary Outcomes
24-month incremental cost-to-utility ratio
Time Frame: At 24 months after inclusion
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
- Rate of surgery for recurrence(At 24 months after inclusion)
- Overall survival(At 24 months after randomization)
- Cost/life-year gained over lifetime horizon(2 years)
- Incremental cost-to-utility ratio(2 years)
- Mean score of Quality of Life(at 3 months, 6 months, 12 months, 18 months and 24 months after randomization)
- Tumor board's decision to treat the patient for recurrence(At 24 months after randomization)
- Cost/complete resection of recurrent disease(At 24 months)
- Duration without treatment(At 24 months after randomization)
- Mean score of HAD (Hospital Anxiety and Depression scale)(at 3 months, 6 months, 12 months, 18 months and 24 months after randomization)
- Rate of complete secondary surgery(At 24 months after inclusion)
- Patient preference on ideal monitoring modalities for patient of interventional group(at 24 month after randomization)
- Number of subjects to be screened to gain one(2 years)
- Budgetary impact at 5 years(At 5 years)
- Change in caregiver preference on ideal monitoring modalities(at randomization and at 24 month after the last patient randomization (end of the study))
- Diagnostic performance of HE4(At 24 months after inclusion)