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Clinical Trials/EUCTR2011-006319-69-ES
EUCTR2011-006319-69-ES
Active, not recruiting
Not Applicable

Closed abdomen hyperthermic intraperitoneal chemotherapy with paclitaxel for advanced epithelial ovarian cancer - Hipecovario

Pedro Villarejo Campos(Hospital Universitario Ciudad Real)0 sitesFebruary 22, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Pedro Villarejo Campos(Hospital Universitario Ciudad Real)
Status
Active, not recruiting
Last Updated
13 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 22, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Pedro Villarejo Campos(Hospital Universitario Ciudad Real)

Eligibility Criteria

Inclusion Criteria

  • \-Women over 18 years with histologically confirmed epithelial ovarian cancer stage II / III / IV (FIGO staging) or tumoral recurrences.
  • \-Complete debulking / optimal: 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, kidney or liver.
  • \-The treatment should be scheduled at least 1 month after the last administration of systemic chemotherapy.
  • \-Women have given their consent to participate in the study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 79

Exclusion Criteria

  • \-Patients who have unresectable peritoneal carcinomatosis or those who can not complete optimal cytoreduction.
  • \-Extrabdominales metastases or unresectable liver metastases or involve a major hepatectomy what conditions a limited hepatic reserve.
  • \-Presence of other malignant tumor disease.
  • \-Multisegmental complete bowel obstruction.
  • \-Active infection or other condition that incapacitate for treatment according to the protocol proposed.
  • \-No specific acceptance of informed consent for this treatment.

Outcomes

Primary Outcomes

Not specified

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