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ClinicalTrials.gov ID

NCT03220932

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

132Estimated

Last Update Posted

Nov 1, 2019Actual

Start Date

Nov 30, 2019Estimated

Primary Completion Date

Nov 30, 2022Estimated

Completion Date

Nov 30, 2022Estimated

Official Title

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

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.

• Ovarian Epithelial Cancer

• Cytoreductive surgery combined with HIPEC
• Chemotherapy and bevacizumab (CT-BEV)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Hospices Civils de LyonOTHER

F-Narducci@o-lambret.fr32 0295 944 ext. +33

clarisse.eveno@chru-lille.fr320 445 962 ext. +33

pierre.meeus@lyon.unicancer.fr478 782 637 ext. +33

isabelle.ray-coquard@lyon.unicancer.fr478 782 888 ext. +33

Pierre-Emmanuel.Colombo@icm.unicancer.fr467 618 501 ext. +33

Veronique.Dhondt@icm.unicancer.fr467 613 151 ext. +33

fabrice.lecuru@egp.aphp.fr156 093 567 ext. +33

benoit.you@chu-lyon.fr478 864 318 ext. +33

naoual.bakrin@chu-lyon.fr478 862 371 ext. +33