Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Systematic Imaging for Follow up of Patients With Ovarian, Fallopian Tube or Primary Peritoneum Cancer (QUALOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04826029
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment Phase
Advanced Stage Serous Epithelial Cancer of the Ovary Advanced Stage Cancer of Tubes Advanced Stage Cancer of Peritoneum Other: Standard strategy Other: Follow-up strategy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Estimated Study Start Date : May 3, 2021
Estimated Primary Completion Date : May 3, 2025
Estimated Study Completion Date : May 3, 2025


Arm Intervention/treatment
Standard arm Other: Standard strategy
In the standard arm, patients will complete CA 125 (+/- HE4) at 3 months, 6 months, 12 months, 18 months and 24 months (+/- 15 days), complete the HAD and EQ5D self-questionnaires, and be managed according to INCa 2018 recommendations. If clinical symptoms, marker elevation, and/or imaging workup occur, the patient will be referred to the multidisciplinary consultation meeting (MDC) for management according to INCa 2018.

Experimental: Interventional arm Other: Follow-up strategy
In the interventional arm, patients will perform at 3 months, 6 months, 12 months, 18 months and 24 months (+/- 15 days) a CA125 assay (+/- HE4 assay), a thoracoabdominal CT scan after contrast injection and a whole body MRI (T2, DW and T1 sequences after fat saturation before and after gadolinium injection) with a maximum delay of 15 days between the two examinations, and will complete the HAD and EQ5D self-questionnaires. A senior radiologist from each center will perform a prospective reading of each of the images. For any suspicious anomaly identified, the following criteria will be analyzed: Size, location, number, evolution, contrast after injection, MRI signal (T2, Diffusion, Dynamic Enhancement Curve). The RECIST criteria (version 1.1) will be applied.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Duration without treatment [ Time Frame: At 24 months after randomization ]
    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)

  2. Mean score of HAD (Hospital Anxiety and Depression scale) [ Time Frame: at 3 months, 6 months, 12 months, 18 months and 24 months after randomization ]
    Hospital Anxiety and Depression scale will be used

  3. Mean score of Quality of Life [ Time Frame: at 3 months, 6 months, 12 months, 18 months and 24 months after randomization ]
    Quality of life of patients will be measured using the EQ5D questionnaire

  4. Overall survival [ Time Frame: At 24 months after randomization ]
    Overall survival is defined as the time from the date of randomization to death regardless of the cause of death.

  5. Tumor board's decision to treat the patient for recurrence [ Time Frame: At 24 months after randomization ]
    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

  6. Rate of complete secondary surgery [ Time Frame: At 24 months after inclusion ]
    To predict the possibility of complete resection of recurrence by surgery

  7. Rate of surgery for recurrence [ Time Frame: At 24 months after inclusion ]
    To compare the percentage of operable patients in each group

  8. Change in caregiver preference on ideal monitoring modalities [ Time Frame: at randomization and at 24 month after the last patient randomization (end of the study) ]

    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.


  9. Patient preference on ideal monitoring modalities for patient of interventional group [ Time Frame: at 24 month after randomization ]

    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.


  10. Diagnostic performance of HE4 [ Time Frame: At 24 months after inclusion ]
    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.

  11. Cost/life-year gained over lifetime horizon [ Time Frame: 2 years ]
    Survival measured by the area between the two Kaplan Meier curves, costs are in euros

  12. Number of subjects to be screened to gain one [ Time Frame: 2 years ]
    Number of subjects to be screened to gain one

  13. Incremental cost-to-utility ratio [ Time Frame: 2 years ]
    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).

  14. Budgetary impact at 5 years [ Time Frame: At 5 years ]
    Costs in euros

  15. Cost/complete resection of recurrent disease [ Time Frame: At 24 months ]
    Cost/complete resection of recurrent disease



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826029


Contacts
Layout table for location contacts
Contact: Catherine Uzan, Pr 01 42 17 81 14 catherine.uzan@aphp.fr

Locations
Layout table for location information
France
Hôpital Pitié Salpêtrière
Paris, France, 75013
Contact: Catherine Uzan, Pr    01 42 17 81 14    catherine.uzan@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Catherine Uzan, Pr Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04826029    
Other Study ID Numbers: APHP200051
2020-A02836-33 ( Other Identifier: ANSM )
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ovarian cancer
Recurrence
Imaging follow up
HE4
CA125
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders