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

NCT04826029 | Withdrawn

• 2 other identifiers: APHP2000512020-A02836-33
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Ovarian cancer; Recurrence; Imaging follow up; HE4; CA125

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

• Mean score of Quality of Life

  at 3 months, 6 months, 12 months, 18 months and 24 months after randomization

• Overall survival

  At 24 months after randomization

• Tumor board's decision to treat the patient for recurrence

  At 24 months after randomization

Study Arms (2)

Standard arm

OTHER

Other: Standard strategy

Interventional arm

EXPERIMENTAL

Other: Follow-up strategy

Interventions

Standard strategy OTHER

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.

Standard arm

Follow-up strategy OTHER

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Uzan, Pr

  Hôpital Pitié Salpêtrière - Assitance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: April 1, 2021
• Study Start: June 22, 2021
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

FR (1)