Intraoperatieve intraperitoneale Chemoperfusie voor de behandeling van minimale residuele ziekte bij stadium III Eierstokkanker: een gerandomiseerde fase II studie.

Phase 1

• Conditions: stage III ovarian cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000418-23-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-04
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

?Tumor type
oBiopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma
?Primary or recurrent disease
?Extent of disease
oPositive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III)
oStage IV with unilateral pleural fluid allowed
oComplete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both
?Second-line patients; platinum sensitive
?Age over 18 years
?No major cardiac or respiratory disease
?Absent or limited (<500ml) clinical ascites
?Adequate performance status (Karnofsky index > 70%)
?Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
?Expected life expectancy more than 6 months
?Laboratory data
oSerum creatinine ? 1.5 mg/dl or a calculated GFR (CKD-EPI) = 60 mL/min/1.73 m2
oSerum total bilirubin ? 1.5 mg/dl, except for known Gilbert’s disease
oPlatelet count > 100.000/µl
oHemoglobin > 9g/dl
oNeutrophil granulocytes > 1.500/ml
oInternational Normalized Ratio (INR) ? 2
?Absence of alcohol and/or drug abuse
?No other concurrent malignant disease
?No inclusion in other clinical trials interfering with the study protocol
?No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
?Absence of any severe organ insufficiency
?No pregnancy or breast feeding
?Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

?Severe or uncontrolled cardiac insufficiency, including recent (< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimal medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension
?Pregnancy or breast feeding
?Platinum resistant (relapse > 12 months after completion of Pt containing therapy) or refractory disease
?Active bacterial, viral or fungal infection
?Active gastro-duodenal ulcer
?Parenchymal liver disease (any stage cirrhosis)
?Uncontrolled diabetes mellitus
?Severe obstructive or restrictive respiratory insufficiency
?Psychiatric pathology capable of affecting comprehension and judgment faculty
?Tumor in the presence of obstruction
?Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis
?Peritoneal cancer index (sPCI) = 25

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of cytoreductive surgery (CRS) and efficacy of cisplatin-based intraoperative intraperitoneal chemoperfusion (IPEC) in patients with primary or recurrent serous epithelial ovarian cancer (OC), in order to treat peritoneal minimal residual disease (pMRD).;Secondary Objective: To study the pharmacodynamics of IP drug delivery and the value of hyperthermic administration.;Primary end point(s): Tissue penetration distance of cisplatin in peritoneal tumor tissue nodules ;Timepoint(s) of evaluation of this end point: end of surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): oPostoperative morbidity and mortality <br>oQuality of Life <br>oPharmacokinetics of cisplatin in peritoneal perfusate and plasma samples<br>oPharmacodynamics: Pt DNA adduct formation<br>oOverall survival, disease free survival, peritoneal recurrence free survival<br>oEffects of (H)IPEC on peritoneal cytology<br>oTranslational research: analyzing gene expression of selected biomarkers for Pt sensitivity, stromal density and composition of tumor slices. ;Timepoint(s) of evaluation of this end point: oPostoperative morbidity and mortality: 30 days after debulking <br>oQuality of Life: preoperatively, after 6 weeks and after 3, 6, 12, 18 and 24 months.