HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy

Launched by INSTITUTO NACIONAL DE CANCEROLOGIA DE MEXICO · Sep 6, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment approach for women with advanced ovarian cancer (specifically stage IIIC and IV) who have not had success with standard treatments. The study is looking at a combination of chemotherapy and a procedure called Hyperthermic Intraperitoneal Chemotherapy (HIPEC), which delivers heated chemotherapy directly into the abdominal cavity after surgery. The aim is to see if this method can improve patient outcomes, reduce side effects, and enhance the quality of life for those affected by this disease.

To participate in the trial, patients generally need to be women under 70 years old with a specific type of ovarian cancer. They should have undergone a few cycles of chemotherapy and shown some positive response to it. Participants can expect to receive care from a dedicated medical team, and they will be closely monitored throughout the process to ensure their safety and well-being. It’s important to know that certain health conditions might exclude individuals from participating, so discussing eligibility with a healthcare provider is essential.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients younger than 70 years
• • 2. Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
• • 3. Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
• • 4. 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.
• • 5. Signature of informed consent.
• • 6. Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
• • 7. ECOG less than or equal to 1
• 8. 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:
• • 1. Patients with heart failure, ischemic heart disease
• • 2. Previous history of treatment with chemotherapy for some other neoplasia
• • 3. History of neuropsychiatric disease
• • 4. Patients with intra operative bleeding that condition hemodynamic instability.
• • 5. Patient requiring more than 2 intraoperative anastomosis