Clinical trial NCT02328716: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peritoneal Carcinomatosis From Ovarian Cancer
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: disease-free survival period
timeFrame: Every 3 months up to 30 months
Secondary outcomes:
measure: Evaluation of overall survival.
timeFrame: Every 3 months up to 30 months
measure: Study of morbidity.
timeFrame: Every 3 months up to 30 months
measure: Evaluation of quality of life related to the procedure.
timeFrame: Every 3 months up to 30 months
measure: Study of Ex vivo correlation.
timeFrame: 4 days post surgery
Other outcomes:
Locations:
city: El Palmar.
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Pedro Cascales Campos, M.D Phd
role: STUDY_DIRECTOR
References:
citation: Cascales Campos PA, Gonzalez-Gil A, Gomez-Ruiz AJ, Gil-Gomez E, Alconchel-Gago F, Navarro-Barrios A, Martinez-Garcia J, Alonso-Romero JL, Nieto A, Barcelo-Valcarcel F, Gil-Martinez J. Risk factors and management of incisional hernia after cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal surface malignancies. Hernia. 2020 Apr;24(2):257-263. doi: 10.1007/s10029-019-01962-4. Epub 2019 May 8.