Feasibility study of hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with stage III or only pleural stage IV ovarian carcinoma in first line therapy. - HIPEC-ovarian carcinoma
- Conditions
- 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 disease3. Age less than 65 years4. ECOG performance status 0-1.5. Adequate bone marrow, hepatic and renal functions.6. No serious cardiac or respiratory illness
- Registration Number
- EUCTR2009-009467-59-BE
- Lead Sponsor
- Institut Jules Bordet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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 < 21
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>to evaluate the morbidity of the treatment<br>;Primary end point(s): Safety profile : mortality rate of the cytoreductive surgery plus HIPEC treatment
- Secondary Outcome Measures
Name Time Method