Status:
RECRUITING
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Conditions:
HPEC
Ovarian Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
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 patie...
Detailed Description
Ovarian cancer ranks seventh in incidence of malignant neoplasms in women younger than 65 years and is the leading cause of cancer death in women in the United States. Due to the absence of an effecti...
Eligibility Criteria
Inclusion
- Patients younger than 70 years
- Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
- Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
- Partial response to treatment with chemotherapy and evaluated by computed tomography (RECIST-see below) and response of at least 50% by serum determination of CA-125 antigen.
- Signature of informed consent.
- Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
- ECOG less than or equal to 1
- Adequate renal, cardiac, hepatic, bone marrow and lung function evaluated preoperatively with the following parameters:
- a) Hb equal to or greater than 10 g / L (pre-treatment transfusion is permitted to achieve this hemoglobin level) b) Leukocytes Greater than 3000 / mm3 (c) Platelets equal to or greater than 100 000 / mm3 (d) total bilirubin less than 1.5 times greater than the normal value e) Hepatic transaminases less than 1.5 times higher than normal value f) Creatinine \<1.2 g / dl. In case of being elevated the measured purification should be greater than 60mL / min according to Cockroft's formula.
- g) Albumin greater than 3gr / dl. h) Left Ventricle Ejection fraction per cardiac echography greater than 55% 9). Sugarbaker carcinomatosis index less than 20
Exclusion
- Patients with heart failure, ischemic heart disease
- Previous history of treatment with chemotherapy for some other neoplasia
- History of neuropsychiatric disease
- Patients with intra operative bleeding that condition hemodynamic instability.
- Patient requiring more than 2 intraoperative anastomosis
Key Trial Info
Start Date :
September 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03275194
Start Date
September 2 2017
End Date
December 1 2026
Last Update
April 28 2023
Active Locations (1)
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1
National Cancer Institute of Mexico
Mexico City, Mexico, 14080