Cost Utility of Radical Surgery in Ovarian Cancer

Not Applicable

Completed

• Conditions: Ovarian Cancer
• Interventions: Other: Collection of additional data with questionnaires

• Registration Number: NCT02854215
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

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).

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 Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Study Start: 2017-01-18
• Status Verified: 2025-04
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian cancer	Collection of additional data with questionnaires	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

Primary Outcome Measures

Name	Time	Method
Cost-utility study	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.

Secondary Outcome Measures

Name	Time	Method
Rate of institutions adherent to INCa quality indicators	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.
Rate of patients "adherent" to INCa quality indicators	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.
Progression Free Survival	5 years and 6 months	Progression Free Survival is defined as the time from inclusion until progression or death from any cause
Quality of life	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
Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients	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).
Overall Survival	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).
Morbidity	5 years and 6 months	Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.

Trial Locations

Locations (10)

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Chu Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Institut Regional Du Cancer Montpellier; 🇫🇷 Montpellier, France

Institut Curie; 🇫🇷 Paris, France

Centre Hospitalier Lyon Sud 2; 🇫🇷 Pierre Benite, France

Centre Hospitalier Lyon Sud 1; 🇫🇷 Pierre Benite, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hopital Nord-Ouest - Villefranche Sur Saone; 🇫🇷 Villefranche-sur-Saône, France