Using HIPEC for advanced ovarian cancer treatment during surgery
Hyperthermic Intraperitoneal Chemotherapy in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy. Phase II Study
This study is testing whether a special type of heated chemotherapy given during surgery can help people with advanced ovarian cancer live better and longer after their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Instituto Nacional de Cancerologia de Mexico Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT03275194 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced ovarian cancer (stage IIIC and IV) who have undergone neoadjuvant chemotherapy followed by interval surgery. The study aims to assess the morbidity and mortality associated with HIPEC and its impact on patients' quality of life. Participants will receive HIPEC after achieving optimal cytoreduction during surgery, with the goal of improving treatment outcomes and reducing recurrence rates. The trial will involve monitoring patient responses and overall health post-treatment.
Who should consider this trial
Good fit: Ideal candidates are women under 70 years old with high-grade serous carcinoma or low-grade endometrioid ovarian cancer at clinical stage IIIC or IVA who have shown a partial response to chemotherapy.
Not a fit: Patients with other types of ovarian cancer or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced ovarian cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in similar contexts, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mexico City
- National Cancer Institute of Mexico — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Rosa A Salcedo-Hernandez, MSc — Instituto Nacional de Cancerologia, Columbia
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.