Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

Last updated: August 19, 2024
Sponsor: ARCAGY/ GINECO GROUP
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Ovarian Cysts

Treatment

Retarded IDS (Interval Debulking Surgery)

Standard IDS (Interval Debulking Surgery)

Clinical Study ID

NCT03579394
GINECO-CHIR101
  • Ages 18-99
  • Female

Study Summary

The aim of CHRONO trial is to compare the DFS when surgery is performed after 3 courses of NACT, or after 6 courses of NACT, in a prospective multi institutional randomized setting,considering only patients initially unsuitable for primary surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female patients ≥18 years.

  2. Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma orprimary peritoneal carcinoma, high grade serous or endometrioïd, with the exceptionof mucinous, clear cell and carcinosarcoma histologies.

  3. Performance status < 2 (see Appendix 2).

  4. Documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1)stage IIIB-IIIC-IVa unsuitable for complete primary cytoreductive surgery (confirmedby open laparoscopy or by laparotomy [not mandatory for stage IVA]).

  5. Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy

  6. Adequate bone marrow, liver and renal function to receive chemotherapy andsubsequently to undergo surgery:

  • White blood cells (WBC) >3x109/L, absolute neutrophil count (ANC) ≥1,5x109/L,platelets (PLT) ≥100x109/L, hemoglobin (Hb) ≥9 g/dL,

  • Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥ 30mL/min according to Cockroft-Gault formula or to local lab measurement, serumbilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.

  1. Signed informed consent obtained prior to any study-specific procedures.

  2. Patient affiliated to, or a beneficiary of, a social security category

Exclusion

Exclusion Criteria:

  1. Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.

  2. Synchronous or previous other malignancies within 3 years prior to starting studytreatment, with the exception of adequately treated non-melanomatous skin cancer orcarcinoma in situ (of the cervix or breast or other sites).

  3. Patients with brain metastases, seizure not controlled with standard medicaltherapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemicattack (TIA) or subarachnoid hemorrhage before 6 months from the enrollment on thisstudy.

  4. Any other concurrent medical conditions contraindicating surgery or chemotherapythat could compromise the adherence to the protocol (including but not limited toimpaired cardiac function or clinically significant cardiac diseases, active oruncontrolled infections, HIV-positive patients on antiretroviral therapy,uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impairedrespiratory function requiring oxygen-dependence, serious psychiatric disorders).

  5. Pregnant or breastfeeding women.

Study Design

Total Participants: 211
Treatment Group(s): 2
Primary Treatment: Retarded IDS (Interval Debulking Surgery)
Phase:
Study Start date:
October 19, 2018
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • ICO Paul Papin

    Angers, 49055
    France

    Site Not Available

  • ICA - Polyclinique Urbain V

    Avignon, 84000
    France

    Site Not Available

  • Hôpital de Beauvais

    Beauvais, 60000
    France

    Site Not Available

  • Institut Bergonié

    Bordeau, 33076
    France

    Site Not Available

  • CHU de BREST - Hôpital Cavale Blanche

    Brest, 29200
    France

    Site Not Available

  • Hôpital Morvan - Centre Hospitalier Universitaire

    Brest, 29200
    France

    Active - Recruiting

  • Centre François Baclesse

    Caen, 14000
    France

    Site Not Available

  • Centre Hospitalier Universitaire Caen

    Caen, 14033
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-ferrand, 63000
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Hôpital Simone Veil

    Eaubonne, 95602
    France

    Site Not Available

  • CHU Grenoble-Alpes - Site Nord (La Tronche)

    Grenoble, 38043
    France

    Site Not Available

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72000
    France

    Site Not Available

  • CHU de Limoges - Hôpital de la Mère et de l'Enfant

    Limoges, 87000
    France

    Site Not Available

  • Hôpital du Scorff

    Lorient, 56100
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69373
    France

    Site Not Available

  • Hôpital Saint-Joseph

    Marseille, 13008
    France

    Site Not Available

  • ICM Val d'Aurelle

    Montpellier, 34298
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes-Hôpital Mère et Enfant

    Nantes, 44093
    France

    Site Not Available

  • Hôpital Privé du Confluent

    Nantes, 44202
    France

    Site Not Available

  • Clinique Hartmann

    Neuilly-sur-seine, 92200
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Groupe Hospitalier Pitié Salpétrière

    Paris, 75651
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hôpital Tenon

    Paris, 75970
    France

    Active - Recruiting

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-benite, 69495
    France

    Site Not Available

  • Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • Institut Jean Godinot

    Reims, 51056
    France

    Site Not Available

  • CHU de Rennes - Hôpital Sud

    Rennes, 35203
    France

    Site Not Available

  • Hôpitaux Drôme Nord - Site de Romans-sur-Isère

    Romans-sur-Isère, 26100
    France

    Site Not Available

  • Hôpital René Huguenin, Institut Curie

    Saint-cloud, 92210
    France

    Site Not Available

  • ICO Centre René Gauducheau

    Saint-herblain, 44805
    France

    Site Not Available

  • Clinique Médico-chirurgicale CHARCOT

    Sainte Foy-les-Lyon, 69110
    France

    Site Not Available

  • Hôpital de Hautepierre

    Strasbourg, 67098
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Centre Hospitalier Universitaire Bretonneau

    Tours, 37000
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

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