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Cost Utility of Radical Surgery in Ovarian Cancer (CURSOC)

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ClinicalTrials.gov Identifier: NCT02854215
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: Collection of additional data with questionnaires Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cost Utility of Radical Surgery in Ovarian Cancer
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Ovarian cancer
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
  • 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 Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854215


Contacts
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Contact: Alejandra MARTINEZ, PhD +33 531 15 51 00 martinez.alejandra@iuct-oncopole.fr

Locations
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France
Institut de Cancerologie de L'Ouest Withdrawn
Angers, France, 49055
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: GUYON Frederic    05 56 33 78 30    f.guyon@bordeaux.unicancer.fr   
Chu Clermont Ferrand Recruiting
Clermont Ferrand, France, 63003
Contact: BOURDEL Nicolas    04 73 75 06 79    nbourdel@chu-clermontferrand.fr   
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Contact: POMEL Christophe       christophe.pomel@cjp.fr   
Centre Oscar Lambret Withdrawn
Lille, France
Institut Paoli Calmettes Recruiting
Marseille, France
Contact: LAMBAUDIE Eric    04 91 22 35 32    lambaudiee@ipc.unicancer.fr   
Institut Regional Du Cancer Montpellier Recruiting
Montpellier, France, 34298
Contact: COLOMBO Pierre Emmanuel    04 67 61 31 50    pierre-emmanuel.colombo@icm.unicancer.fr   
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Fabrice LECURU    01 56 09 35 84    fabrice.lecuru@aphp.fr   
Institut Curie Recruiting
Paris, France, 75248
Contact: POUGET Nicolas    01 56 24 59 14    nicolas.pouget@curie.fr   
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: GERTYCH Witold    04 78 86 41 78    witold.gertych@chu-lyon.fr   
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: BAKRIN Naoual    04 78 86 23 71    naoual.bakrin@chu-lyon.fr   
Clinique Mutualiste de La Sagesse Withdrawn
Rennes, France, 35043
Institut de Cancerologie de L'Ouest Withdrawn
Saint Herblain, France, 44805
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: MARTINEZ Alejandra    05 31 15 53 66    martinez.alejandra@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT02854215     History of Changes
Other Study ID Numbers: 15GENF03
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma