Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer (NCT02681432) | Clinical Trial Compass
UnknownPhase 3
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer
Spain60 participantsStarted 2012-01
Plain-language summary
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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Inclusion Criteria:
* Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
* Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
* No extra-abdominal tumor disease
* Absence of heart failure. Adequate renal and hepatic functions
* Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Exclusion Criteria:
* Patients with unresectable tumor or incomplete cytoreduction.
* Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count \<1.500/mm3 (\<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
* Extra-abdominal metastases or unresectable liver metastases
* Presence of other malignant tumor disease.
* Multisegmental complete bowel obstruction.
* Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
* Patients who refuse treatment or consent to participate in study