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OncoMatch/Clinical Trials/NCT03275194

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

Is NCT03275194 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for hpec.

Phase 2RecruitingInstituto Nacional de Cancerologia de MexicoNCT03275194Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Disease stage

Required: Stage IIIC, IVA (CYTOLOGY-POSITIVE PLEURAL EFFUSION)

Clinical stage IIIC and IVA (cytology-positive pleural effusion)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: platinum-based chemotherapy (carboplatin) — induction

induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL

Must have received: taxane (paclitaxel) — induction

induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL

Cannot have received: chemotherapy for some other neoplasia

Previous history of treatment with chemotherapy for some other neoplasia

Lab requirements

Blood counts

Hb ≥ 10 g/L (pre-treatment transfusion permitted); leukocytes > 3000/mm3; platelets ≥ 100,000/mm3

Kidney function

Creatinine <1.2 g/dl; if elevated, measured purification >60 mL/min (Cockroft's formula)

Liver function

total bilirubin < 1.5x normal; hepatic transaminases < 1.5x normal

Cardiac function

Left Ventricle Ejection fraction > 55% by echography

Adequate renal, cardiac, hepatic, bone marrow and lung function evaluated preoperatively with the following parameters: Hb ≥ 10 g/L (pre-treatment transfusion is permitted); Leukocytes > 3000/mm3; Platelets ≥ 100,000/mm3; total bilirubin < 1.5x normal; hepatic transaminases < 1.5x normal; Creatinine <1.2 g/dl, if elevated measured purification >60 mL/min (Cockroft's formula); Albumin > 3g/dl; Left Ventricle Ejection fraction > 55% by echography

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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