Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial.
- Conditions
- Peritoneal carcinomatosis from ovarian cancer, fallopian tube or primary peritoneal carcinoma.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2011-001715-31-ES
- Lead Sponsor
- Fundación para la Formación e Investigación Sanitaria de la Región de Murcia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 126
- Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
- Residual tumor < 2.5 mm after completion of cytoreductive surgery.
- Aged < 75 years.
- Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
- Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
- Adequate renal function with creatinine ? 1.5 mg/ dl.
- Adequate liver function with bilitubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
- Optimal cardiopulmonary function.
- In recurrences, disease-free interval > 6 months.
- Voluntary and signed written infromed consent.
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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63
- Extraperitoneal tumor disease.
- Suboptimal debulking (residual tumor > 2.5 mm).
- Previous history of other malignancies (excluding skin)
- Intestinal obstruction at the time of evaluation.
- Renal failure.
- Heart failure.
- Uncontrolled infection.
- Pregnant or lactating patients.
- In recurrences, disease-free interval < 6 months.
- Hypersensitivity to cispñatin previously.
- Have been subjected to a procedure previously HIPEC.
- Denial of diseased part of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method