Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Wounds and Injuries

Rare Diseases

Behaviors and Mental Disorders

Recurrence

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperthermia

Fever

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Quality of Life

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Cisplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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

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

Cytoreductive surgery combined with HIPEC

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

Chemotherapy and bevacizumab (CT-BEV)

Naoual BARKIN, MD,PhD

Laurent VILLENEUVE

Brice PAQUETTE, MD

Fernando BAZAN, MD

Fabrice NARDUCCI, MD

Clarisse EVENO, MD

Pierre MEEUS, MD

Isabelle RAY-COQUARD, MD

Pierre-Emmanuel COLOMBO, MD

Véronique D'HONDT, MD

Jérôme DELOTTE, MD

Jean Marc BEREDER, MD

Delphine OUVRIER, MD

Fabrice LECURU, MD

Benoit YOU, MD

Naoual BAKRIN, MD

Nadia RABAN, MD

Karine ABBOUD, MD

Céline CHAULEUR, MD

Romain RIVOIRARD, MD

Cécile BRIGAND, MD

Emmanuel KURTZ, MD

Chérif AKLADIOS, MD

Frédéric MARCHAL, MD

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.

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

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

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.

There is a follow-up period of 36 months.

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

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

Hospices Civils de Lyon

Spots Global Cancer Trial Database for cytoreductive surgery combined with hipec