RecruitingPhase 2NCT03275194

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

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy. Phase II Study


Sponsor

Instituto Nacional de Cancerologia de Mexico

Enrollment

100 participants

Start Date

Sep 2, 2017

Study Type

INTERVENTIONAL

Conditions

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 patients are candidates for standard treatment, which is primary cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of peritoneal dissemination, whose morbidity and mortality has been reported in several series and is promising as a management option for ovarian cancer, so it is necessary to evaluate morbidity and mortality that conditions this modality of treatment as well as if it impacts on the quality of life of the patients to whom they are performed, which will allow offering our patients an option of additional treatment to the standard.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a heated chemotherapy wash directly into the abdominal cavity (called HIPEC) during surgery improves survival for women with advanced ovarian cancer who have responded well to initial chemotherapy. **You may be eligible if...** - You are younger than 70 years old - You have been diagnosed with high-grade serous or low-grade endometrioid ovarian cancer at Stage IIIC or IVA (with fluid around the lungs only) - You have received 3–4 cycles of carboplatin and paclitaxel chemotherapy and shown at least a 50% response - During surgery, your surgeon is able to remove almost all visible tumor (less than 2.5 mm remaining) - Your heart, liver, kidneys, lungs, and blood counts are in adequate condition **You may NOT be eligible if...** - You have heart failure or coronary artery disease - You have previously received chemotherapy for another cancer - You have a history of neuropsychiatric disease - Severe bleeding occurs during surgery - You need more than 2 bowel reconnections during surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHIPEC

Following complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.


Locations(1)

National Cancer Institute of Mexico

Mexico City, Mexico

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NCT03275194


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