Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer
HIPOVA-01
Assessment of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer
1 other identifier
interventional
132
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2019
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
November 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedNovember 1, 2019
October 1, 2019
3 years
May 11, 2017
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline to 36 months
Secondary Outcomes (4)
Overall survival
From the randomization to the death or 36 months end of follow-up
Potential treatment-related mortality
During the first 60 postoperative days
Potential treatment-related morbidity
During the first 60 postoperative days
Quality of life assessment
Baseline to 36 months end of follow-up
Study Arms (2)
Cytoreductive surgery combined with HIPEC
EXPERIMENTALAll 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
Aurelia arm
ACTIVE COMPARATORChemotherapy and bevacizumab (CT-BEV) once every 3 weeks from enrollment until disease progression
Interventions
Cytoreductive surgery combined with HIPEC (Cisplatin 70 mg/m2).
Chemotherapy and bevacizumab (CT-BEV) 15 mg/kg once every 3 weeks from enrollment until disease progression (RECIST 1.1)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25030, France
Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25030, France
Centre Oscar Lambret
Lille, 59000, France
CHRU Claude Huriez
Lille, 59067, France
Centre Léon Bérard
Lyon, 69008, France
Centre Léon Bérard
Lyon, 69008, France
Institut du Cancer de Montpellier
Montpellier, 34298, France
Institut du Cancer de Montpellier
Montpellier, 34298, France
Centre Hospitalier Universitaire L'Archet II
Nice, 06200, France
Centre Hospitalier Universitaire L'Archet II
Nice, 06200, France
Centre Hospitalier Universitaire L'Archet II
Nice, 06200, France
Hôpital Européen Georges Pompidou - APHP
Paris, 75015, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Centre Hospitalier Universitaire de St Etienne
Saint-Priest-en-Jarez, 42270, France
Centre Hospitalier Universitaire de St Etienne
Saint-Priest-en-Jarez, 42270, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, France
Centre Hospitalier Universitaire Hautepierre
Strasbourg, 67200, France
Centre Hospitalier Universitaire Hautepierre
Strasbourg, 67200, France
Centre Hospitalier Universitaire Hautepierre
Strasbourg, 67200, France
Institut de Cancérologie de Lorraine - Alexis Vautrin
Vandœuvre-lès-Nancy, 54519, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
July 18, 2017
Study Start
November 30, 2019
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
November 1, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share