Inclusion criteria : 1. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma. 2. FIGO stage III disease or only pleural stage IV disease 3. Age less than 65 years 4. ECOG performance status 0-1. 5. Adequate bone marrow, hepatic and renal functions. 6. No serious cardiac or respiratory illness
Conditions
Interventions
Trade Name: Platosin
Pharmaceutical Form: Solution for injection
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma. 2. FIGO stage III disease or only pleural stage IV disease 3. Age less than 65 years 4. ECOG performance status 0-1. 5. Adequate bone marrow, hepatic and renal functions. 6. No serious cardiac or respiratory illness 7. No major co morbidity such as diabetes or other condition that might hamper the postoperative recuperation. 8. preoperative chemotherapy with carboplatinum-paclitaxel is recommended for lower surgical morbidity (3 courses). 9. PCI (peritoneal carcinomatosis index) score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. metastatic disease in other sites than pleural 2. age higher than 65 years 3. ECOG PS 2 or higher 4. serious cardiac or respiratory illness 5. major co morbidity 6. impaired bone marrow, hepatic and renal functions 7. PCI score equal or higher than 21
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility study evaluating the safety of hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with stage III or only pleural stage IV ovarian carcinoma in first line therapy.;Secondary Objective: To evaluate the efficacy in terms of progression free survival (PFS) and overall survival (OS) of the treatment to evaluate the morbidity of the treatment ;Primary end point(s): Safety profile : mortality rate of the cytoreductive surgery plus HIPEC treatment | — |
Countries
Belgium
Outcome results
None listed