Ovarian CancerCURSOCNCT02854215
Cost Utility of Radical Surgery in Ovarian Cancer
A study testing Collection of additional data with questionnaires in people with Ovarian Cancer, run by Institut Claudius Regaud at 10 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Collection of additional data with questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesFrance
- Study dates
- 18 Jan 2017to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut Bergonie
Bordeaux, 33076
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Centre Jean Perrin
Clermont-Ferrand, 63011
Institut Paoli Calmettes
Marseille
Institut Regional Du Cancer Montpellier
Montpellier, 34298
Institut Curie
Paris, 75248
Centre Hospitalier Lyon Sud 1
Pierre-Bénite, 69495
Centre Hospitalier Lyon Sud 2
Pierre-Bénite, 69495
Institut Claudius Regaud
Toulouse, 31059
Hopital Nord-Ouest - Villefranche Sur Saone
Villefranche-sur-Saône, 69655
About this study
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).
Read the 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).
- Conditions
- Ovarian Cancer
- Being tested
- Collection of additional data with questionnaires
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of additional data with questionnairesOther
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Collection of additional data with questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years and 6 months
Secondary outcomes (7)
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.
Measured: 2 years and 6 months
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.
Measured: 2 years and 6 months
Quality of life
The quality of life will be evaluated according to the QLQ-C30, QLQ-0V28 and the EQ-5D-3L questionnaires
Measured: 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
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).
Measured: 5 years and 6 months
Progression Free Survival
Progression Free Survival is defined as the time from inclusion until progression or death from any cause
Measured: 5 years and 6 months
Overall Survival
Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data).
Measured: 5 years and 6 months
Morbidity
Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.
Measured: 5 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start18 Jan 2017
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854215
- Sponsor's protocol ID
- 15GENF03
- Acronym
- CURSOC
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2016
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33808284Filleron 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.
PubMed 29608972
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Utility of Radical Surgery in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02854215
- Acronym / sponsor ID
- CURSOC / 15GENF03
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer | Other | Other: Collection of additional data with questionnairesPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of additional data with questionnaires* 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). | Other | Ovarian cancer |
Primary outcome
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.
7 secondary outcomes
Rate of institutions adherent to INCa quality indicators
Time frame: 2 years and 6 months
Rate of patients "adherent" to INCa quality indicators
Time frame: 2 years and 6 months
Quality of life
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
Time frame: 5 years and 6 months
Progression Free Survival
Time frame: 5 years and 6 months
Overall Survival
Time frame: 5 years and 6 months
Morbidity
Time frame: 5 years and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 33808284Alejandra 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.
- Derived from this study: PubMed 29608972Filleron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of additional data with questionnaires in people with Ovarian Cancer, run by Institut Claudius Regaud at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility study (time frame: 5 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854215, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.