Using HIPEC for advanced ovarian cancer treatment during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Cancer Institute of Mexico
  Mexico City, Mexico Recruiting

Study contacts

• Principal investigator: Rosa A Salcedo-Hernandez, MSc — Instituto Nacional de Cancerologia, Columbia

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• VT-101 in Advanced Ovarian Cancer: early safety study in adults

  This early-phase trial tests VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer to see if it is safe, how the body handles it, and whether there are any initial signs of activity.

  Recruiting Phase 1 University of Iowa · Iowa City, Iowa · NCT07905677

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• EHR-based approach to boost HBOC genetic testing in at-risk women

  A new EHR tool-based program tests whether computer prompts and real patient resources can help more women with family histories of breast or ovarian cancer get HBOC genetic testing.

  Recruiting Columbia University · New York, New York · NCT07876349

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.