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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02328716

Acronym

CARCINOHIPEC

Enrollment

Registered

2014-12-31

Start date

2012-02-29

Completion date

2018-12-31

Last updated

2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

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.

Interventions

PROCEDURECytoreduction

Cytoreduction

DRUGHipec with Cisplatin

Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
disease-free survival period	Every 3 months up to 30 months	Every three months until recurrence of disease.

Secondary

Measure	Time frame	Description
Evaluation of overall survival.	Every 3 months up to 30 months	Every three months until recurrence of disease.
Study of morbidity.	Every 3 months up to 30 months	Every three months until recurrence of disease.
Evaluation of quality of life related to the procedure.	Every 3 months up to 30 months	Every three months until recurrence of disease.
Study of Ex vivo correlation.	4 days post surgery	in vitro cell culture to study the effect of temperature and cisplatin on cell viability

Countries

Spain

Contacts

Primary ContactPedro Cascales Campos, MD,PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026