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NCT Number: NCT02854215

Cost Utility of Radical Surgery in Ovarian Cancer

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonie, Bordeaux, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Cost-utility study

    Time frame: 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 outcomes

  1. Rate of institutions adherent to INCa quality indicators

    Time frame: 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.

  2. Rate of patients "adherent" to INCa quality indicators

    Time frame: 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.

  3. Quality of life

    Time frame: 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

  4. Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients

    Time frame: 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).

  5. Progression Free Survival

    Time frame: 5 years and 6 months

    Progression Free Survival is defined as the time from inclusion until progression or death from any cause

  6. Overall Survival

    Time frame: 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).

  7. Morbidity

    Time frame: 5 years and 6 months

    Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: CURSOC

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2016
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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