Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer (hipecova)

August 17, 2018 updated by: PEDRO VILLAREJO CAMPOS

Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization:

  • HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
  • No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Ciudad Real
        • Contact:
          • Javier Redondo-Calvo, MD PhD
        • Principal Investigator:
          • Pedro Villarejo Campos, MD,PhD
        • Sub-Investigator:
          • Javier Redondo Calvo, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
  • Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
  • No extra-abdominal tumor disease
  • Absence of heart failure. Adequate renal and hepatic functions
  • Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%

Exclusion Criteria:

  • Patients with unresectable tumor or incomplete cytoreduction.
  • Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
  • Extra-abdominal metastases or unresectable liver metastases
  • Presence of other malignant tumor disease.
  • Multisegmental complete bowel obstruction.
  • Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
  • Patients who refuse treatment or consent to participate in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HIPEC
Primary ovarian cancer FIGO stage II, III or IV or recurrent
Drug: HIPEC
Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.
ACTIVE_COMPARATOR: No HIPEC
Primary ovarian cancer FIGO stage II, III or IV or recurrent
Procedure: No HIPEC
Cytoreductive surgery without HIPEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: every 6 months till 36 months
From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)
every 6 months till 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: follow up every 6 months till 18 months
From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months)
follow up every 6 months till 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE))
Compare adverse events between study arms
adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PEDRO VILLAREJO CAMPOS

Collaborators

University of Castilla-La Mancha
Hospital General de Ciudad Real

Investigators

  • Principal Investigator: Pedro Villarejo Campos, MD, PhD, SESCAM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (ESTIMATE)

February 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGCRCIRU001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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