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

NCT ID: NCT02328716

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peritoneal Carcinomatosis From Ovarian Cancer Fallopian Tube Carcinoma Primary Peritoneal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Comparator

Comparator

Group Type ACTIVE_COMPARATOR

Cytoreduction

Intervention Type PROCEDURE

Cytoreduction

Experimental

Experimental

Group Type EXPERIMENTAL

Cytoreduction

Intervention Type PROCEDURE

Cytoreduction

Hipec with Cisplatin

Intervention Type DRUG

Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Interventions

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Cytoreduction

Cytoreduction

Intervention Type PROCEDURE

Hipec with Cisplatin

Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Cascales Campos, M.D Phd

Role: STUDY_DIRECTOR

Hospital Universitario Virgen de la Arrixaca

Locations

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Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Pedro Cascales Campos, MD,PhD

Role: CONTACT

Facility Contacts

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Pedro Cascales Campos

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31069579 (View on PubMed)

Other Identifiers

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2011-001715-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EC-GC/AD-01/11

Identifier Type: -

Identifier Source: org_study_id