Cost Utility of Radical Surgery in Ovarian Cancer (CURSOC)

April 9, 2026 updated by: Institut Claudius Regaud
The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, comparative and non-randomized study designed to investigate the medico-economic impact of adherence to INCa guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).

A cost-utility study will be performed. It will primarily aim to assess the Incremental Cost-Utility Ratio (ICUR) at 3 years of the two treatment strategies of ovarian cancer surgery: adherence to INCa quality indicators versus non-adherence to INCa quality indicators.

Consecutive patients with stage IIIC and IV ovarian, tubal, and primary peritoneal malignancies will be recruited in different health care institutions, including comprehensive cancer centers, university hospitals and private hospitals.

Evaluation of adherence to quality indicators will be assessed retrospectively (once patients have completed the treatment) by two independent experts.

200 patients will be included over a period of 2 years and will be followed for a 3 years period after treatment (every 4 months the first two years and then every 6 months).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand
      • Marseille, France
        • Institut Paoli Calmettes
      • Montpellier, France, 34298
        • Institut regional du Cancer Montpellier
      • Paris, France, 75248
        • Institut Curie
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud 1
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud 2
      • Toulouse, France, 31059
        • Institut Claudius Regaud
      • Villefranche-sur-Saône, France, 69655
        • Hopital Nord-Ouest - Villefranche Sur Saone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Woman with age ≥ 18 years.
  • 2. Newly diagnosed ovarian, tubal or peritoneal malignancies.
  • 3. Epithelial histology.
  • 4. Stage IIIC or IVA with extrapelvic carcinomatosis according to FIGO classification 2014.
  • 5. Patients undergoing primary surgery or neoadjuvant chemotherapy.
  • 6. Performance Status ≤ 2.
  • 7. Patient affiliated to a Social Health Insurance in France.
  • 8. Patient information and informed consent form signed prior to any study specific procedures.

Exclusion Criteria:

  • 1. Benign or borderline tumors.
  • 2. Patients with extra-abdominal disease, except for pleural effusion with positive cytology.
  • 3. Other malignancy diagnosed in the previous 5 years except skin cancer (other than melanoma).
  • 4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
  • 5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ovarian cancer
Patient undergoing primary surgery for a newly diagnosed ovarian, tubal or peritoneal malignancies; Stage IIIc or IVa with extrapelvic carcinomatosis according to the International Federation of Gynecology and Obstetrics classification 2014
Other: Collection of additional data with questionnaires
  • questionnaires for quality of life measurements: QLQC30; QLQ-OV28
  • questionnaires for medico-economic purposes: ADL (activities of daily living); IADL (instrumental activities of daily living); EQ-5D3L; absenteeism questionnaire.

These questionnaires will be completed during the study time (5 or 6 times during the treatment, next every 4 months during the first two years and then every 6 months during the third year of follow-up).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-utility study
Time Frame: 5 years and 6 months
The primary endpoint is defined as cost per Quality-Adjusted Life Year (QALY) at 3 years. Patient utilities will be obtained from the EuroQoL 5D-3L questionnaire.
5 years and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of institutions adherent to INCa quality indicators
Time Frame: 2 years and 6 months
The rate of institutions adherent to INCa quality indicators corresponds to the number of institutions adherent to INCa quality indicators among the total number of institutions.
2 years and 6 months
Rate of patients "adherent" to INCa quality indicators
Time Frame: 2 years and 6 months
The rate of patients "adherent" to INCa quality indicators corresponds to the number of patients adherent to INCa quality indicators among the total number of patients.
2 years and 6 months
Quality of life
Time Frame: 5 years and 6 months
The quality of life will be evaluated according to the QLQ-C30, QLQ-0V28 and the EQ-5D-3L questionnaires
5 years and 6 months
Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients
Time Frame: 5 years and 6 months
Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients using costs data collected from the French insurance databases, Medical Information Departments of each participating centers and from patients' questionnaires (treatment costs, other induced costs and avoided costs).
5 years and 6 months
Progression Free Survival
Time Frame: 5 years and 6 months
Progression Free Survival is defined as the time from inclusion until progression or death from any cause
5 years and 6 months
Overall Survival
Time Frame: 5 years and 6 months
Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data).
5 years and 6 months
Morbidity
Time Frame: 5 years and 6 months
Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.
5 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2017

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimated)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15GENF03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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