ovarian cancer treatment with intraabdominal chemotherapy (paclitaxel)

• Conditions: ovarian cancer (II,III,IV FIGO staging and tumoral recurrence); MedDRA version: 14.1Level: LLTClassification code 10028584Term: MyelosuppressionSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.1Level: PTClassification code 10006093Term: BradycardiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10028813Term: NauseaSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: LLTClassification code 10012727Term: DiarrheaSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: PTClassification code 10047700Term: VomitingSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: LLTClassification code 10028127Term: MucositisSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: LLTClassification code 10034610Term: Peripheral neuropathy NOSSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10003239Term: ArthralgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: PTClassification code 10001760Term: AlopeciaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2011-006319-69-ES
• Lead Sponsor: Pedro Villarejo Campos(Hospital Universitario Ciudad Real)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-22
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To measure adverse effects and complications in patients who applies closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel.<br> -To compare the morbidity and mortality of closed abdomen hyperthermia intraperitoneal chemotherapy in relation to morbidity and mortality reported in the literature for open abdomen hyperthermia intraperitoneal chemotherapy of advanced ovarian cancer;Primary end point(s): -Overall survival and progression-free survival;Timepoint(s) of evaluation of this end point: The trial design included 94 patients. The study is presented in two steps, a first step would include the first 40 patients. So when patients grade 3 complications exceeds from 40% and / or grade 4 complications exceeds from 20% and / or mortality exceeds from 10% of the study should be stopped.;Main Objective: Assessment of therapeutic efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in advanced ovarian cancer or tumoral recurrences

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NO;Timepoint(s) of evaluation of this end point: NO