Cost Utility of Radical Surgery in Ovarian Cancer

Ovarian Cancer Clinical Trial

— CURSOC  

Official title:

Cost Utility of Radical Surgery in Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02854215
• Other study ID #: 15GENF03
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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).

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Centre Jean Perrin	Clermont Ferrand
France	Chu Clermont Ferrand	Clermont Ferrand
France	Institut Paoli Calmettes	Marseille
France	Institut Regional Du Cancer Montpellier	Montpellier
France	Institut Curie	Paris
France	Centre Hospitalier Lyon Sud 1	Pierre Benite
France	Centre Hospitalier Lyon Sud 2	Pierre Benite
France	Institut Claudius Regaud	Toulouse
France	Hopital Nord-Ouest - Villefranche Sur Saone	Villefranche-sur-Saône

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

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