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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02328716
Other study ID # EC-GC/AD-01/11
Secondary ID 2011-001715-31
Status Recruiting
Phase Phase 3
First received December 5, 2014
Last updated December 12, 2017
Start date February 2012
Est. completion date December 2018

Study information

Verified date December 2017
Source Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Contact Pedro Cascales Campos , MD ,PhD
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cytoreduction
Cytoreduction
Drug:
Hipec with Cisplatin
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Locations

Country Name City State
Spain Hospital Clínico Universitario Virgen de la Arrixaca El Palmar. Murcia

Sponsors (1)

Lead Sponsor Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

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