Cost Utility of Radical Surgery in Ovarian Cancer

NCT02854215 | Completed

• 1 other identifier: 15GENF03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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).

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of institutions adherent to INCa quality indicators

  2 years and 6 months

• Rate of patients "adherent" to INCa quality indicators

  2 years and 6 months

• Quality of life

  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

  5 years and 6 months

• Progression Free Survival

  5 years and 6 months

Study Arms (1)

Ovarian cancer

OTHER

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

Interventions

Collection of additional data with questionnaires OTHER

* 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).

Ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Woman with age ≥ 18 years.
• \. Newly diagnosed ovarian, tubal or peritoneal malignancies.
• \. Epithelial histology.
• \. Stage IIIC or IVA with extrapelvic carcinomatosis according to FIGO classification 2014.
• \. Patients undergoing primary surgery or neoadjuvant chemotherapy.
• \. Performance Status ≤ 2.
• \. Patient affiliated to a Social Health Insurance in France.
• \. Patient information and informed consent form signed prior to any study specific procedures.

You may not qualify if:

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

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (10)

Institut Bergonie

Bordeaux, 33076, France

Location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Institut Regional Du Cancer Montpellier

Montpellier, 34298, France

Location

Institut Curie

Paris, 75248, France

Location

Centre Hospitalier Lyon Sud 1

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Lyon Sud 2

Pierre-Bénite, 69495, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Hopital Nord-Ouest - Villefranche Sur Saone

Villefranche-sur-Saône, 69655, France

Location

Related Publications (2)

• Alejandra M, Gertych W, Pomel C, Ferron G, Lusque A, Angeles MA, Lambaudie E, Rouzier R, Bakrin N, Golfier F, Glehen O, Canis M, Bourdel N, Pouget N, Colombo PE, Guyon F, Meurette J, Querleu D. Adherence to French and ESGO Quality Indicators in Ovarian Cancer Surgery: An Ad-Hoc Analysis from the Prospective Multicentric CURSOC Study. Cancers (Basel). 2021 Mar 30;13(7):1593. doi: 10.3390/cancers13071593.

  PMID: 33808284 BACKGROUND

• 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.

  PMID: 29608972 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 3, 2016
• Study Start: January 18, 2017
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (10)