Brief Title
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma
Official Title
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.
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
disease-free survival period
Secondary Outcome
Evaluation of overall survival.
Condition
Peritoneal Carcinomatosis From Ovarian Cancer
Intervention
Cytoreduction
Study Arms / Comparison Groups
Comparator
Description: Comparator
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
32
Start Date
February 2012
Completion Date
December 2018
Primary Completion Date
December 2018
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Pedro Cascales Campos, M.D Phd, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02328716
Organization ID
EC-GC/AD-01/11
Secondary IDs
2011-001715-31
Responsible Party
Sponsor
Study Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study Sponsor
Pedro Cascales Campos, M.D Phd, Study Director, Hospital Universitario Virgen de la Arrixaca
Verification Date
December 2017