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Trial record 5 of 534 for:    "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 (CARCINOHIPEC)

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ClinicalTrials.gov Identifier: NCT02328716
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis From Ovarian Cancer Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Procedure: Cytoreduction Drug: Hipec with Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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.
Actual Study Start Date : February 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Comparator
Comparator
Procedure: Cytoreduction
Cytoreduction

Experimental: Experimental
Experimental
Procedure: Cytoreduction
Cytoreduction

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




Primary Outcome Measures :
  1. disease-free survival period [ Time Frame: Every 3 months up to 30 months ]
    Every three months until recurrence of disease.


Secondary Outcome Measures :
  1. Evaluation of overall survival. [ Time Frame: Every 3 months up to 30 months ]
    Every three months until recurrence of disease.

  2. Study of morbidity. [ Time Frame: Every 3 months up to 30 months ]
    Every three months until recurrence of disease.

  3. Evaluation of quality of life related to the procedure. [ Time Frame: Every 3 months up to 30 months ]
    Every three months until recurrence of disease.

  4. Study of Ex vivo correlation. [ Time Frame: 4 days post surgery ]
    in vitro cell culture to study the effect of temperature and cisplatin on cell viability



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328716


Contacts
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Contact: Pedro Cascales Campos , MD ,PhD

Locations
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Spain
Hospital Clínico Universitario Virgen de la Arrixaca Recruiting
El Palmar., Murcia, Spain, 30120
Contact: Pedro Cascales Campos    968369500      
Principal Investigator: Pedro Cascales Campos, M.D         
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Investigators
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Study Director: Pedro Cascales Campos, M.D Phd Hospital Universitario Virgen de la Arrixaca

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Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT02328716     History of Changes
Other Study ID Numbers: EC-GC/AD-01/11
2011-001715-31 ( EudraCT Number )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Cisplatin
Antineoplastic Agents