Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

PEDRO VILLAREJO CAMPOS60 enrolled

Overview

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

Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization: * HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles. * No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epithelial Ovarian Cancer

Interventions

HIPECDRUG

Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.

No HIPECPROCEDURE

Cytoreductive surgery without HIPEC

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital General Ciudad Real

Ciudad Real, Spain

RECRUITING

Outcomes

Primary Outcomes

Overall survival

From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)

Time frame: every 6 months till 36 months

Secondary Outcomes

Progression free survival

From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months)

Time frame: follow up every 6 months till 18 months

Central Contacts

Pedro Villarejo Campos, MD,PhD

CONTACT

926278000 villarejocampos@yahoo.es

Data from ClinicalTrials.gov

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