Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma (CARCINOHIPEC)

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status and phase: Unknown; Phase 3

Conditions: Primary Peritoneal Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinomatosis From Ovarian Cancer

Treatments: Procedure: Cytoreduction; Drug: Hipec with Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02328716

EC-GC/AD-01/11

2011-001715-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 bilirubin 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 informed consent.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Comparator

Active Comparator group

Description:

Comparator

Treatment:

Procedure: Cytoreduction

Experimental

Experimental group

Description:

Experimental

Treatment:

Drug: Hipec with Cisplatin

Procedure: Cytoreduction