Cost Utility of Radical Surgery in Ovarian Cancer (CURSOC)

Institut Claudius Regaud

Status: Completed

Conditions: Ovarian Cancer

Treatments: Other: Collection of additional data with questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT02854215

15GENF03

Details and patient eligibility

About

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).

Full 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).

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Ovarian cancer

Other group

Description:

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

Treatment:

Other: Collection of additional data with questionnaires