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

NCT04826029 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-12-10

No results posted yet for this study

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

Conditions

  • Advanced Stage Serous Epithelial Cancer of the Ovary
  • Advanced Stage Cancer of Tubes
  • Advanced Stage Cancer of Peritoneum

Interventions

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.

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Catherine Uzan, Pr · Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2021-06-22
Completion
2021-06-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826029 on ClinicalTrials.gov