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Cytoreductive Surgery and HIP...

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

NCT ID: NCT03220932

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Epithelial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cytoreductive surgery combined with HIPEC

Intervention Type PROCEDURE

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

Aurelia arm

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

Group Type ACTIVE_COMPARATOR

Chemotherapy and bevacizumab (CT-BEV)

Intervention Type DRUG

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

Interventions

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Cytoreductive surgery combined with HIPEC

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

Intervention Type PROCEDURE

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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers