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Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer (HIPOVA-01)

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ClinicalTrials.gov Identifier: NCT03220932
Recruitment Status : Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

With 4,600 new cases in France in 2012, ovarian cancer is the seventh most common cancer in women and the fourth cause of mortality by cancer. Despite a high response rate to initial treatment, most patients will relapse within 2 years. No standard treatment has yet been established for patients with recurrent ovarian cancer.

Most patients with such recurrences are currently treated with new combinations of systemic chemotherapy. A repeated laparotomy with complete cytoreduction is also an option that several authors have used to obtain median survival rates of more than 30 months.

Twenty five percent of patients experiencing relapse present with platinum-resistant recurrence, occurring less than 6 months after chemotherapy completion. Recently, Pujade et al. showed that adding bevacizumab to chemotherapy significantly improves progression-free survival (PFS) in this subgroup of patients with poor prognoses (16.6 months versus 13.3 months in women treated with chemotherapy alone). Three case control studies have compared systemic chemotherapy and CRS (Cytoreduction Surgery) alone versus CRS plus HIPEC in patients with recurrent disease. They showed significantly improved results with the addition of HIPEC. In the French registry that included 474 patients with recurrence and peritoneal carcinomatosis, the median PFS was 13.8 months for platinum-resistant patients and 13 months for platinum-sensitive patients. Our hypothesis is that surgery would reduce the tumor burden and consequently the number of platinum-resistant tumor clones and that HIPEC would control the microscopic residual disease by increasing the tumor cell cytotoxicity.

We assume that adding a locoregional treatment to an "Aurelia-like" systemic treatment would improve the PFS. We aim to assess the benefit of adding surgery and HIPEC to the treatment of first or second platinum-resistant recurrence compared to chemotherapy + bevacizumab.


Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Procedure: Cytoreductive surgery combined with HIPEC Drug: Chemotherapy and bevacizumab (CT-BEV) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022


Arm Intervention/treatment
Experimental: Cytoreductive surgery combined with HIPEC
All patients will start with three cycles of CT-BEV 15 mg/kg, and will then be randomly. Then one cycle of monochemotherapy without bevacizumab is administered and followed by an interval CRS and HIPEC with postoperative chemotherapy and bevacizumab (CT-BEV - 15 mg/kg once every 3 weeks) until disease progression
Procedure: Cytoreductive surgery combined with HIPEC
Cytoreductive surgery combined with HIPEC (Cisplatin 70 mg/m2).

Active Comparator: Aurelia arm
Chemotherapy and bevacizumab (CT-BEV) once every 3 weeks from enrollment until disease progression
Drug: Chemotherapy and bevacizumab (CT-BEV)
Chemotherapy and bevacizumab (CT-BEV) 15 mg/kg once every 3 weeks from enrollment until disease progression (RECIST 1.1)




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Change from baseline to 36 months ]
    Progression will be based on RECIST V1.1 criteria performed on thoraco-abdominopelvic tomodensitometry (TDM ) assessed every 3 months. There is a follow-up period of 36 months.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the randomization to the death or 36 months end of follow-up ]
    There is a follow-up period of 36 months.

  2. Potential treatment-related mortality [ Time Frame: During the first 60 postoperative days ]
    Reported only in the experimental arm (cytoreductive surgery + HIPEC)

  3. Potential treatment-related morbidity [ Time Frame: During the first 60 postoperative days ]
    Adverse events (AE) during the follow-up period: safety and tolerability will be assessed in terms of AEs, deaths, laboratory data, and vital signs. AEs will be described using MedDRA terms (version 18.0) and graded according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). These will be collected for all randomized patients.

  4. Quality of life assessment [ Time Frame: Baseline to 36 months end of follow-up ]
    Quality of Life will be assessed using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) for all randomized patients.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed platinum-resistant Epithelial Ovarian Carcinoma (EOC)(clinical recurrence or persistence within 6 months of last treatment);
  • White blood cells >3,500/mm3, neutrophils ≥1,500/mm3, platelets ≥100,000/mm3;
  • Good renal function: serum creatinine values <1.5 mg/dl, creatinine clearance >60 ml/min;
  • Performance Status ≤2, Karnofsky Index ≥70%;
  • Serum bilirubin ≤1.5 x Upper limit of normal (UNL) 2 mg/dl;
  • Prior ovarian surgery before starting study treatment;
  • Covered by a Healthcare System, where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
  • Signed written informed consent obtained prior to any study-specific screening procedures.

Exclusion Criteria:

  • Platinum-refractory EOC (i.e progression under platinum containing chemotherapy);
  • Any prior malignancy not considered in complete remission for at least 2 years;
  • Pregnancy or breastfeeding;
  • Untreated central nervous system disease or symptomatic central nervous system metastasis, history or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment;
  • Uncontrolled hypertension or active clinically significant cardiovascular disease;
  • Females of childbearing age not using medically accepted contraceptive measures, as judged by the investigator;
  • Contraindication to any drug contained in the chemotherapy regimen;
  • Known contraindication to cisplatin
  • Medical, geographical, sociological, psychological or legal conditions that would prevent the patient from completing the study or signing the informed consent;
  • Any significant disease which, in the investigator's opinion, excludes the patient from the study;
  • Under any administrative or legal supervision.

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): NCT03220932


Contacts
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Contact: Naoual BARKIN, MD,PhD 4 78 86 23 71 ext +33 naoual.bakrin@chu-lyon.fr
Contact: Laurent VILLENEUVE 78 86 45 36 ext +33 laurent.villeneuve@chu-lyon.fr

Locations
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France
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France, 25030
Contact: Brice PAQUETTE, MD    381 668 970 ext +33    bpaquette@chu-besancon.fr   
Principal Investigator: Brice PAQUETTE, MD         
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France, 25030
Contact: Fernando BAZAN, MD    381 479 999 ext +33    fbazan@chu-besancon.fr   
Principal Investigator: Fernando BAZAN, MD         
Centre Oscar Lambret
Lille, France, 59000
Contact: Fabrice NARDUCCI, MD    32 0295 944 ext +33    F-Narducci@o-lambret.fr   
Principal Investigator: Fabrice NARDUCCI, MD         
CHRU Claude Huriez
Lille, France, 59067
Contact: Clarisse EVENO, MD    320 445 962 ext +33    clarisse.eveno@chru-lille.fr   
Principal Investigator: Clarisse EVENO, MD         
Centre Léon Bérard
Lyon, France, 69008
Contact: Pierre MEEUS, MD    478 782 637 ext +33    pierre.meeus@lyon.unicancer.fr   
Principal Investigator: Pierre MEEUS, MD         
Centre Léon Bérard
Lyon, France, 69008
Contact: Isabelle RAY-COQUARD, MD    478 782 888 ext +33    isabelle.ray-coquard@lyon.unicancer.fr   
Principal Investigator: Isabelle RAY-COQUARD, MD         
Institut du Cancer de Montpellier
Montpellier, France, 34298
Contact: Pierre-Emmanuel COLOMBO, MD    467 618 501 ext +33    Pierre-Emmanuel.Colombo@icm.unicancer.fr   
Principal Investigator: Pierre-Emmanuel COLOMBO, MD         
Institut du Cancer de Montpellier
Montpellier, France, 34298
Contact: Véronique D'HONDT, MD    467 613 151 ext +33    Veronique.Dhondt@icm.unicancer.fr   
Principal Investigator: Véronique D'HONDT, MD         
Centre Hospitalier Universitaire L'Archet II
Nice, France, 06200
Contact: Jérôme DELOTTE, MD    492 035 948 ext +33    delotte.j@chu-nice.fr   
Principal Investigator: Jérôme DELOTTE, MD         
Centre Hospitalier Universitaire L'Archet II
Nice, France, 06200
Contact: Jean Marc BEREDER, MD    4 92 03 64 86 ext +33    bereder.jm@chu-nice.fr   
Principal Investigator: Jean Marc BEREDER, MD         
Centre Hospitalier Universitaire L'Archet II
Nice, France, 06200
Contact: Delphine OUVRIER, MD    492 037 777 ext +33    ouvrier.d@chu-nice.fr   
Principal Investigator: Delphine OUVRIER, MD         
Hôpital Européen Georges Pompidou - APHP
Paris, France, 75015
Contact: Fabrice LECURU, MD    156 093 567 ext +33    fabrice.lecuru@egp.aphp.fr   
Principal Investigator: Fabrice LECURU, MD         
Centre Hospitalier Lyon Sud
Pierre-benite, France, 69495
Contact: Benoit YOU, MD    478 864 318 ext +33    benoit.you@chu-lyon.fr   
Principal Investigator: Benoit YOU, MD         
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Contact: Naoual BAKRIN, MD    478 862 371 ext +33    naoual.bakrin@chu-lyon.fr   
Principal Investigator: Naoual BAKRIN, MD         
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86021
Contact: Nadia RABAN, MD    549 444 444 ext +33    nadia.raban@chu-poitiers.fr   
Principal Investigator: Nadia RABAN, MD         
Centre Hospitalier Universitaire de St Etienne
Saint-priest-en-jarez, France, 42270
Contact: Karine ABBOUD, MD    477 828 337 ext +33    karine.abboud@chu-st-etienne.fr   
Principal Investigator: Karine ABBOUD, MD         
Centre Hospitalier Universitaire de St Etienne
Saint-Priest-en-Jarez, France, 42270
Contact: Céline CHAULEUR, MD    477 828 287 ext +33    celine.chauleur@chu-st-etienne.fr   
Principal Investigator: Céline CHAULEUR, MD         
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France, 42270
Contact: Romain RIVOIRARD, MD    477 917 134 ext +33    romain.rivoirard@icloire.fr   
Principal Investigator: Romain RIVOIRARD, MD         
Centre Hospitalier Universitaire Hautepierre
Strasbourg, France, 67200
Contact: Cécile BRIGAND, MD    388 127 226 ext +33    cecile.brigand@chru-strasbourg.fr   
Principal Investigator: Cécile BRIGAND, MD         
Centre Hospitalier Universitaire Hautepierre
Strasbourg, France, 67200
Contact: Emmanuel KURTZ, MD    388 128 436 ext +33    j-emmanuel.kurtz@chru-strasbourg.fr   
Principal Investigator: Emmanuel KURTZ, MD         
Centre Hospitalier Universitaire Hautepierre
Strasbourg, France, 67200
Contact: Chérif AKLADIOS, MD    388 127 492 ext +33    Cherif.youssef.azer@chru-strasbourg.fr   
Principal Investigator: Chérif AKLADIOS, MD         
Institut de Cancérologie de Lorraine - Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54519
Contact: Frédéric MARCHAL, MD    383 598 451 ext +33    f.marchal@nancy.unicancer.fr   
Principal Investigator: Frédéric MARCHAL, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03220932    
Other Study ID Numbers: 69HCL17_0342
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Epithelial Ovarian Cancer - Platinum-resistant - Cytoreductive surgery - HIPEC - Quality of Life
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors