Actively Recruiting
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2023-04-28
100
Participants Needed
1
Research Sites
482 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ovarian cancer is the leading cause of gynecological cancer mortality, with no current screening method effective for early diagnosis, with 75% of advanced stage patients being detected. Not all patients are candidates for standard treatment, which is primary cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of peritoneal dissemination, whose morbidity and mortality has been reported in several series and is promising as a management option for ovarian cancer, so it is necessary to evaluate morbidity and mortality that conditions this modality of treatment as well as if it impacts on the quality of life of the patients to whom they are performed, which will allow offering our patients an option of additional treatment to the standard.
CONDITIONS
Official Title
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients younger than 70 years
- Diagnosis of high grade serous carcinoma of the ovary or low-grade endometrioid carcinoma confirmed by pathology
- Clinical stage IIIC or IVA ovarian cancer with positive pleural cytology
- Received 3 or 4 cycles of carboplatin and paclitaxel chemotherapy
- Partial response to chemotherapy with at least 50% reduction by CT scan and CA-125 antigen levels
- Signed informed consent
- Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
- ECOG performance status 0 or 1
- Adequate organ function including hemoglobin ≥10 g/L, leukocytes >3000/mm3, platelets ≥100,000/mm3, total bilirubin <1.5 times normal, liver enzymes <1.5 times normal, creatinine <1.2 g/dl or clearance >60 mL/min, albumin >3 g/dl, and left ventricular ejection fraction >55%
- Sugarbaker carcinomatosis index less than 20
You will not qualify if you...
- Heart failure or ischemic heart disease
- Previous chemotherapy treatment for another cancer
- History of neuropsychiatric disease
- Intraoperative bleeding causing hemodynamic instability
- Requirement of more than two intraoperative anastomoses
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Institute of Mexico
Mexico City, Mexico, 14080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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