A study to see whether an extra rinse with chemotherapy during surgery will prolong the life of ovarian cancer patients
- Conditions
- stage III epithelial ovarian cancerMedDRA version: 20.0Level: PTClassification code 10033163Term: Ovarian epithelial cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003346-17-DK
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- 535
- signed and written informed consent
- age =18
- candidate for primary CRS, in whom a complete cytoreduction, or cytoreducion with no more than 2.5 mm residual disease is considered feasible
- histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
- fit for major surgery, ASA 1 or ASA 2
- WHO performance status 0 t/m2
- adequate bone marrow, hepatic and renal function
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.history of previous malignancies within 5 years prior to inclusion
2.FIGO stage IV disease
3.if complete primary cytoreduction is impossible
4.patients who received prior treatment for the current malignancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method