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

Primary Purpose

Ovarian Epithelial Cancer

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Cytoreductive surgery combined with HIPEC

Chemotherapy and bevacizumab (CT-BEV)

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer focused on measuring Epithelial Ovarian Cancer - Platinum-resistant - Cytoreductive surgery - HIPEC - Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cytoreductive surgery combined with HIPEC

Aurelia arm

Arm Description

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

Chemotherapy and bevacizumab (CT-BEV) once every 3 weeks from enrollment until disease progression

Outcomes

Primary Outcome Measures

Progression free survival

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

Overall survival

There is a follow-up period of 36 months.

Potential treatment-related mortality

Reported only in the experimental arm (cytoreductive surgery + HIPEC)

Potential treatment-related morbidity

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.

Quality of life assessment

Quality of Life will be assessed using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) for all randomized patients.

Full Information

NCT ID

NCT03220932

First Posted

May 11, 2017

Last Updated

October 31, 2019

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT03220932

Brief Title

Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer

Acronym

HIPOVA-01

Official Title

Assessment of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 30, 2019 (Anticipated)

Primary Completion Date

November 30, 2022 (Anticipated)

Study Completion Date

November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Ovarian Epithelial Cancer

Keywords

Epithelial Ovarian Cancer - Platinum-resistant - Cytoreductive surgery - HIPEC - Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cytoreductive surgery combined with HIPEC

Arm Type

Experimental

Arm Description

Arm Title

Aurelia arm

Arm Type

Active Comparator

Arm Description

Chemotherapy and bevacizumab (CT-BEV) once every 3 weeks from enrollment until disease progression

Intervention Type

Procedure

Intervention Name(s)

Cytoreductive surgery combined with HIPEC

Intervention Description

Cytoreductive surgery combined with HIPEC (Cisplatin 70 mg/m2).

Intervention Type

Drug

Intervention Name(s)

Chemotherapy and bevacizumab (CT-BEV)

Intervention Description

Chemotherapy and bevacizumab (CT-BEV) 15 mg/kg once every 3 weeks from enrollment until disease progression (RECIST 1.1)

Primary Outcome Measure Information:

Title

Progression free survival

Description

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.

Time Frame

Change from baseline to 36 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

There is a follow-up period of 36 months.

Time Frame

From the randomization to the death or 36 months end of follow-up

Title

Potential treatment-related mortality

Description

Reported only in the experimental arm (cytoreductive surgery + HIPEC)

Time Frame

During the first 60 postoperative days

Title

Potential treatment-related morbidity

Description

Time Frame

During the first 60 postoperative days

Title

Quality of life assessment

Description

Quality of Life will be assessed using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) for all randomized patients.

Time Frame

Baseline to 36 months end of follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Naoual BARKIN, MD,PhD

Phone

4 78 86 23 71

Ext

+33

naoual.bakrin@chu-lyon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Laurent VILLENEUVE

Phone

78 86 45 36

Ext

+33

laurent.villeneuve@chu-lyon.fr

Facility Information:

Facility Name

Centre Hospitalier Universitaire Jean Minjoz

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brice PAQUETTE, MD

Phone

381 668 970

Ext

+33

bpaquette@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Brice PAQUETTE, MD

Facility Name

Centre Hospitalier Universitaire Jean Minjoz

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando BAZAN, MD

Phone

381 479 999

Ext

+33

fbazan@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Fernando BAZAN, MD

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabrice NARDUCCI, MD

Phone

32 0295 944

Ext

+33

F-Narducci@o-lambret.fr

First Name & Middle Initial & Last Name & Degree

Fabrice NARDUCCI, MD

Facility Name

CHRU Claude Huriez

City

Lille

ZIP/Postal Code

59067

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clarisse EVENO, MD

Phone

320 445 962

Ext

+33

clarisse.eveno@chru-lille.fr

First Name & Middle Initial & Last Name & Degree

Clarisse EVENO, MD

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre MEEUS, MD

Phone

478 782 637

Ext

+33

pierre.meeus@lyon.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Pierre MEEUS, MD

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle RAY-COQUARD, MD

Phone

478 782 888

Ext

+33

isabelle.ray-coquard@lyon.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Isabelle RAY-COQUARD, MD

Facility Name

Institut du Cancer de Montpellier

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-Emmanuel COLOMBO, MD

Phone

467 618 501

Ext

+33

Pierre-Emmanuel.Colombo@icm.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Pierre-Emmanuel COLOMBO, MD

Facility Name

Institut du Cancer de Montpellier

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Véronique D'HONDT, MD

Phone

467 613 151

Ext

+33

Veronique.Dhondt@icm.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Véronique D'HONDT, MD

Facility Name

Centre Hospitalier Universitaire L'Archet II

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jérôme DELOTTE, MD

Phone

492 035 948

Ext

+33

delotte.j@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Jérôme DELOTTE, MD

Facility Name

Centre Hospitalier Universitaire L'Archet II

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Marc BEREDER, MD

Phone

4 92 03 64 86

Ext

+33

bereder.jm@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Jean Marc BEREDER, MD

Facility Name

Centre Hospitalier Universitaire L'Archet II

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Delphine OUVRIER, MD

Phone

492 037 777

Ext

+33

ouvrier.d@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Delphine OUVRIER, MD

Facility Name

Hôpital Européen Georges Pompidou - APHP

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabrice LECURU, MD

Phone

156 093 567

Ext

+33

fabrice.lecuru@egp.aphp.fr

First Name & Middle Initial & Last Name & Degree

Fabrice LECURU, MD

Facility Name

Centre Hospitalier Lyon Sud

City

Pierre-benite

ZIP/Postal Code

69495

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit YOU, MD

Phone

478 864 318

Ext

+33

benoit.you@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Benoit YOU, MD

Facility Name

Centre Hospitalier Lyon Sud

City

Pierre-Bénite

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Naoual BAKRIN, MD

Phone

478 862 371

Ext

+33

naoual.bakrin@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Naoual BAKRIN, MD

Facility Name

Centre Hospitalier Universitaire de Poitiers

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadia RABAN, MD

Phone

549 444 444

Ext

+33

nadia.raban@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

Nadia RABAN, MD

Facility Name

Centre Hospitalier Universitaire de St Etienne

City

Saint-priest-en-jarez

ZIP/Postal Code

42270

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karine ABBOUD, MD

Phone

477 828 337

Ext

+33

karine.abboud@chu-st-etienne.fr

First Name & Middle Initial & Last Name & Degree

Karine ABBOUD, MD

Facility Name

Centre Hospitalier Universitaire de St Etienne

City

Saint-Priest-en-Jarez

ZIP/Postal Code

42270

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Céline CHAULEUR, MD

Phone

477 828 287

Ext

+33

celine.chauleur@chu-st-etienne.fr

First Name & Middle Initial & Last Name & Degree

Céline CHAULEUR, MD

Facility Name

Institut de Cancérologie de la Loire

City

Saint-Priest-en-Jarez

ZIP/Postal Code

42270

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Romain RIVOIRARD, MD

Phone

477 917 134

Ext

+33

romain.rivoirard@icloire.fr

First Name & Middle Initial & Last Name & Degree

Romain RIVOIRARD, MD

Facility Name

Centre Hospitalier Universitaire Hautepierre

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cécile BRIGAND, MD

Phone

388 127 226

Ext

+33

cecile.brigand@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Cécile BRIGAND, MD

Facility Name

Centre Hospitalier Universitaire Hautepierre

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuel KURTZ, MD

Phone

388 128 436

Ext

+33

j-emmanuel.kurtz@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Emmanuel KURTZ, MD

Facility Name

Centre Hospitalier Universitaire Hautepierre

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chérif AKLADIOS, MD

Phone

388 127 492

Ext

+33

Cherif.youssef.azer@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Chérif AKLADIOS, MD

Facility Name

Institut de Cancérologie de Lorraine - Alexis Vautrin

City

Vandœuvre-lès-Nancy

ZIP/Postal Code

54519

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédéric MARCHAL, MD

Phone

383 598 451

Ext

+33

f.marchal@nancy.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Frédéric MARCHAL, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer

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

Ovarian Epithelial Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial