HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
HPEC, Ovarian Cancer, Women's Health: Neoplasm of Ovary
About this trial
This is an interventional treatment trial for HPEC
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- National Cancer Institute of MexicoRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control group
HIPEC group
After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm does not receive additional treatment and the procedure will be finished.
After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm receive a HIPEC procedure with cisplatin and doxorubicin.