Ovarian cancer MedDRA version: 14.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: up to
Concentration number: 75-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age over 18 and under 70 years -Patients affected by a first recurrence of ovarian cancer with measurable or not measurable lesions, but evaluable (upwards of Ca125 for 2 consecutive assessments). -ECOG-performance status = 2 -Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation -Evidence of tumor recurrence diagnosed after 6 months from primary treatment -Previous-based chemotherapy of carboplatin and taxanes -Peritoneal Washing-positive in the presence of other abdominal disease surgically resectable -Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count> 1500 / mm3, platelets> 150 000/µl, creatinine clearance> 60 mL / min according to Cockroft formula) -Patient-compliant and psychologically able to follow the trial procedures Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: -Non-epithelial ovarian cancer or borderline ovarian tumor -Pregnancy or breastfeeding -Patients affected by major depressive disorder even in treatment or minor mood disorders -Patients with severe impairment of respiratory, hepatic or renal function -Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease -Patients with active infection or other neoplastic disease in progress -Patients with bowel obstruction -Inadequate bone marrow, liver, kidney function -No clear-peritoneal disease at surgical exploration -Patients with ascites> 500 ml (the TAC) -Patients on maintenance therapy with Antiangiogenic -Patients with secondary or tertiary recurrence, or already submitted to HIPEC -Patients who have already made the second or third line chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -Estimate of overall survival (OS)in the two trial arms. -Evaluation of the morbidity and mortality in the two trial arms -Evaluation of the second recurrence pattern in the two trial arms -Stratification of survival data in relation to the appearance of first recurrence between 6 and 12 months compared to its appearance after 12 months. -Stratification of survival data in relation to the value of PCI (Peritoneal Cancer Index) and to the residual disease (CC-0 vs CC-1) -Evaluation of quality of life (QOL) before surgery, 30 days after surgery, during chemotherapy and during follow-up (as shown in the temporal trial schedule), with EORTC QLQ-C30 and QLQ OV28 questionnaires. -Estimate of patients who will be able to start postoperative chemotherapy within 5 weeks from surgery made in the two trial arms;Primary end point(s): -Estimate of progression free interval (PFI) in the two trial arms.;Timepoint(s) of evaluation of this end point: na;Main Objective: To assess disease progression-free interval after surgery combined with intraperitoneal chemo-hyperthermia with respect to the exclusive secondary cytoreduction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Estimate of overall survival (OS)in the two trial arms. - Evaluation of the morbidity and mortality in the two trial arms - Evaluation of the second recurrence pattern in the two trial arms - Stratification of survival data in relation to the appearance of first recurrence between 6 and 12 months compared to its appearance after 12 months. - Stratification of survival data in relation to the value of PCI (Peritoneal Cancer Index) and to the residual disease (CC-0 vs CC-1) - Evaluation of quality of life (QOL) before surgery, 30 days after surgery, during chemotherapy and during follow-up (as shown in the temporal trial schedule), with EORTC QLQ-C30 and QLQ OV28 questionnaires. - Estimate of patients who will be able to start postoperative chemotherapy within 5 weeks from surgery made in the two trial arms;Timepoint(s) of evaluation of this end point: na | — |
Countries
Italy
Contacts
Public ContactGinecologia oncologica
Policlinico Gemelli
Outcome results
None listed