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Cost Utility of Radical Surgery in Ovarian Cancer (CURSOC)

Primary Purpose

Ovarian Cancer

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of additional data with questionnaires
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Institut Bergonie
  • Chu Clermont Ferrand
  • Centre Jean Perrin
  • Institut Paoli Calmettes
  • Institut Regional Du Cancer Montpellier
  • Institut Curie
  • Centre Hospitalier Lyon Sud 1
  • Centre Hospitalier Lyon Sud 2
  • Institut Claudius Regaud
  • Hopital Nord-Ouest - Villefranche Sur Saone

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ovarian cancer

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of institutions adherent to INCa quality indicators
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
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
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
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
Progression Free Survival is defined as the time from inclusion until progression or death from any cause
Overall Survival
Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data).
Morbidity
Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.

Full Information

First Posted
July 29, 2016
Last Updated
August 2, 2023
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT02854215
Brief Title
Cost Utility of Radical Surgery in Ovarian Cancer
Acronym
CURSOC
Official Title
Cost Utility of Radical Surgery in Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ovarian cancer
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Collection of additional data with questionnaires
Intervention Description
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 Outcome Measure Information:
Title
Cost-utility study
Description
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.
Time Frame
5 years and 6 months
Secondary Outcome Measure Information:
Title
Rate of institutions adherent to INCa quality indicators
Description
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.
Time Frame
2 years and 6 months
Title
Rate of patients "adherent" to INCa quality indicators
Description
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.
Time Frame
2 years and 6 months
Title
Quality of life
Description
The quality of life will be evaluated according to the QLQ-C30, QLQ-0V28 and the EQ-5D-3L questionnaires
Time Frame
5 years and 6 months
Title
Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients
Description
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).
Time Frame
5 years and 6 months
Title
Progression Free Survival
Description
Progression Free Survival is defined as the time from inclusion until progression or death from any cause
Time Frame
5 years and 6 months
Title
Overall Survival
Description
Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data).
Time Frame
5 years and 6 months
Title
Morbidity
Description
Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.
Time Frame
5 years and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Chu Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Institut Regional Du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Hospitalier Lyon Sud 1
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Lyon Sud 2
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Nord-Ouest - Villefranche Sur Saone
City
Villefranche-sur-Saône
ZIP/Postal Code
69655
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29608972
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.
Results Reference
derived

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Cost Utility of Radical Surgery in Ovarian Cancer

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