CURSOC: Cost Utility of Radical Surgery in Ovarian Cancer

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02854215

Collaborator

(none)

200

Enrollment

Locations

Arm

100.4

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Other: Collection of additional data with questionnaires	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Cost Utility of Radical Surgery in Ovarian Cancer

Actual Study Start Date :

Jan 18, 2017

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.
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).
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Woman with age ≥ 18 years.
1. Newly diagnosed ovarian, tubal or peritoneal malignancies.
1. Epithelial histology.
1. Stage IIIC or IVA with extrapelvic carcinomatosis according to FIGO classification

1. Patients undergoing primary surgery or neoadjuvant chemotherapy.
1. Performance Status ≤ 2.
1. Patient affiliated to a Social Health Insurance in France.
1. Patient information and informed consent form signed prior to any study specific procedures.

Exclusion Criteria:

1. Benign or borderline tumors.
1. Patients with extra-abdominal disease, except for pleural effusion with positive cytology.
1. Other malignancy diagnosed in the previous 5 years except skin cancer (other than melanoma).
1. 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.
1. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Bergonie	Bordeaux	France	33076
2	Chu Clermont Ferrand	Clermont Ferrand	France	63003
3	Centre Jean Perrin	Clermont Ferrand	France	63011
4	Institut Paoli Calmettes	Marseille	France
5	Institut Regional Du Cancer Montpellier	Montpellier	France	34298
6	Institut Curie	Paris	France	75248
7	Centre Hospitalier Lyon Sud 1	Pierre Benite	France	69495
8	Centre Hospitalier Lyon Sud 2	Pierre Benite	France	69495
9	Institut Claudius Regaud	Toulouse	France	31059
10	Hopital Nord-Ouest - Villefranche Sur Saone	Villefranche-sur-Saône	France	69655

Sponsors and Collaborators

Institut Claudius Regaud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Claudius Regaud

ClinicalTrials.gov Identifier:

NCT02854215

Other Study ID Numbers:

15GENF03

First Posted:

Aug 3, 2016

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Aug 3, 2022