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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 (CARCINOHIPEC)

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Cytoreduction
Hipec with Cisplatin
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peritoneal Carcinomatosis From Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comparator

Experimental

Arm Description

Comparator

Experimental

Outcomes

Primary Outcome Measures

disease-free survival period
Every three months until recurrence of disease.

Secondary Outcome Measures

Evaluation of overall survival.
Every three months until recurrence of disease.
Study of morbidity.
Every three months until recurrence of disease.
Evaluation of quality of life related to the procedure.
Every three months until recurrence of disease.
Study of Ex vivo correlation.
in vitro cell culture to study the effect of temperature and cisplatin on cell viability

Full Information

First Posted
December 5, 2014
Last Updated
December 12, 2017
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT02328716
Brief Title
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma
Acronym
CARCINOHIPEC
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Comparator
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cytoreduction
Intervention Description
Cytoreduction
Intervention Type
Drug
Intervention Name(s)
Hipec with Cisplatin
Intervention Description
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin
Primary Outcome Measure Information:
Title
disease-free survival period
Description
Every three months until recurrence of disease.
Time Frame
Every 3 months up to 30 months
Secondary Outcome Measure Information:
Title
Evaluation of overall survival.
Description
Every three months until recurrence of disease.
Time Frame
Every 3 months up to 30 months
Title
Study of morbidity.
Description
Every three months until recurrence of disease.
Time Frame
Every 3 months up to 30 months
Title
Evaluation of quality of life related to the procedure.
Description
Every three months until recurrence of disease.
Time Frame
Every 3 months up to 30 months
Title
Study of Ex vivo correlation.
Description
in vitro cell culture to study the effect of temperature and cisplatin on cell viability
Time Frame
4 days post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Cascales Campos, MD,PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Cascales Campos, M.D Phd
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar.
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Cascales Campos
Phone
968369500
First Name & Middle Initial & Last Name & Degree
Pedro Cascales Campos, M.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
31069579
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.
Results Reference
derived

Learn more about this trial

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

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