ovarian cancer (II,III,IV FIGO staging and tumoral recurrence) MedDRA version: 14.1 Level: LLT Classification code 10028584 Term: Myelosuppression System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1 Level: PT Classification code 10006093 Term: Bradycardia System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: PT Classification code 10028813 Term: Nausea System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Le
Conditions
Interventions
Trade Name: paclitaxel teva
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
Pedro Villarejo Campos(Hospital Universitario Ciudad Real)
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To measure adverse effects and complications in patients who applies closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel. -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
| Measure | Time frame |
|---|---|
| Secondary end point(s): NO;Timepoint(s) of evaluation of this end point: NO | — |
Countries
Spain
Contacts
Public Contactsecretaria unidad de investigacion
unidad de investigacion (hospital universitario de ciudad real)
Outcome results
None listed