Clinical trial NCT02854215: Cost Utility of Radical Surgery in Ovarian Cancer
Official title: Cost Utility of Radical Surgery in Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Cost-utility study
timeFrame: 5 years and 6 months
Secondary outcomes:
measure: Rate of institutions adherent to INCa quality indicators
timeFrame: 2 years and 6 months
measure: Rate of patients "adherent" to INCa quality indicators
timeFrame: 2 years and 6 months
measure: Quality of life
timeFrame: 5 years and 6 months
measure: Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients
timeFrame: 5 years and 6 months
measure: Progression Free Survival
timeFrame: 5 years and 6 months
measure: Overall Survival
timeFrame: 5 years and 6 months
measure: Morbidity
timeFrame: 5 years and 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont Ferrand
country: France
facility: Chu Clermont Ferrand
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Institut Regional Du Cancer Montpellier
city: Paris
country: France
facility: Institut Curie
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud 1
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud 2
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villefranche-sur-Saône
country: France
facility: Hopital Nord-Ouest - Villefranche Sur Saone
Study officials:
References:
citation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.