Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PEDRO VILLAREJO CAMPOS
• Collaborators: Hospital General de Ciudad Real; University of Castilla-La Mancha
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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