HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy

April 26, 2023 updated by: Rosa A. Salcedo, Instituto Nacional de Cancerologia de Mexico

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy. Phase II Study

Ovarian cancer is the leading cause of gynecological cancer mortality, with no current screening method effective for early diagnosis, with 75% of advanced stage patients being detected. Not all patients are candidates for standard treatment, which is primary cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of peritoneal dissemination, whose morbidity and mortality has been reported in several series and is promising as a management option for ovarian cancer, so it is necessary to evaluate morbidity and mortality that conditions this modality of treatment as well as if it impacts on the quality of life of the patients to whom they are performed, which will allow offering our patients an option of additional treatment to the standard.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ovarian cancer ranks seventh in incidence of malignant neoplasms in women younger than 65 years and is the leading cause of cancer death in women in the United States. Due to the absence of an effective screening method and early symptoms, 70% of the cases are diagnosed in advanced clinical stage (stage III or IV) and the overall 5-year survival is 30-40%.

The standard treatment of locally advanced ovarian carcinoma is primary cytoreductive surgery plus adjuvant chemotherapy with carboplatin and taxanes. In cases where it is not possible to perform primary cytoreductive surgery a treatment option is to start with induction chemotherapy (three or four cycles), in order to reduce tumor size and volume, after which it is performed an interval surgery, during which it has been reported that optimal cytoreduction is achieved in 77-94% of patients, with lower morbidity and mortality than primary surgery, without oncological compromise. Subsequent to interval surgery three additional cycles of chemotherapy are applied.

Despite an adequate response to the treatment aforementioned, 70% of patients will recur within the first two years. Because of this high recurrence rate, other therapeutic alternatives have been evaluated, among them is hyperthermic intraperitoneal chemotherapy (HIPEC). Since its first description 20 years ago, the HIPEC associated with cytoreductive surgery in the treatment of malignant neoplasms (primary or metastatic) in the peritoneal surface has become the standard of treatment, specifically in patients with peritoneal pseudomyxoma, peritoneal mesothelioma, and cancer with limited peritoneal involvement. In ovarian cancer, attempts are being made to determine its usefulness in specific scenarios of this disease.

The increasing interest in the use of HIPEC in the management of advanced ovarian cancer is based on the coelomic dissemination of ovarian cancer, which in theory would allow this modality of treatment to be effective. Moreover, optimal cytoreduction and administration of intraperitoneal chemotherapy over intravenous (intraperitoneal normothermy) have been shown to be superior in achieving higher survival rates in randomised trials.

Few groups in the world have studied the use of HIPEC in ovarian cancer, however, studies have been (and are being conducted) in the following scenarios: a) during primary cytoreduction, b) during interval laparotomy, c) as consolidation after standard treatment, d) recurrence of platinum resistant carcinoma and e) in the recurrence of "platinum sensitive" carcinoma. The morbidity of this procedure reported in different series is 33-39%, and mortality of 0-9%. The feasibility of the procedure with low rates of morbidity and mortality has been reported, specially when the treatment is done by a multidisciplinary group especially trained in HIPEC.

The present project is a Phase II, randomised study whose primary objective is to evaluate the morbidity, mortality, and quality of life of patients undergoing HIPEC during the surgery with optimal surgical cytoreduction. One group will be treated with cytoreduction and adjuvant chemotherapy, while the experimental group will be treated with cytoreduction followed by HIPEC. Our secondary objectives are the assessment of the disease-free period and overall survival. The working hypothesis is that the use of HIPEC during interval surgery will have a morbidity considered as acceptable as reported in the literature without significant deterioration in the quality of life.

The importance of evaluating this new therapeutic tool is that any of the current treatments for ovarian cancer have a high rate of recurrence. Based in the evidence, biological behaviour and pattern of dissemination of ovarian cancer, treatment should incorporate both systemic and locoregional therapy, because the neoplasm spreads via coelomic, lymphatic and hematogenous. The use of HIPEC together with the surgical event of cytoreduction could avoid recurrence and allow us to distinguish those patients who are candidates for this procedure and their actual benefit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • National Cancer Institute of Mexico
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients younger than 70 years
  2. Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
  3. Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
  4. Partial response to treatment with chemotherapy and evaluated by computed tomography (RECIST-see below) and response of at least 50% by serum determination of CA-125 antigen.
  5. Signature of informed consent.
  6. Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
  7. ECOG less than or equal to 1

  8. Adequate renal, cardiac, hepatic, bone marrow and lung function evaluated preoperatively with the following parameters:

    a) Hb equal to or greater than 10 g / L (pre-treatment transfusion is permitted to achieve this hemoglobin level) b) Leukocytes Greater than 3000 / mm3 (c) Platelets equal to or greater than 100 000 / mm3 (d) total bilirubin less than 1.5 times greater than the normal value e) Hepatic transaminases less than 1.5 times higher than normal value f) Creatinine <1.2 g / dl. In case of being elevated the measured purification should be greater than 60mL / min according to Cockroft's formula.

    g) Albumin greater than 3gr / dl. h) Left Ventricle Ejection fraction per cardiac echography greater than 55% 9). Sugarbaker carcinomatosis index less than 20

Exclusion Criteria:

  1. Patients with heart failure, ischemic heart disease
  2. Previous history of treatment with chemotherapy for some other neoplasia
  3. History of neuropsychiatric disease
  4. Patients with intra operative bleeding that condition hemodynamic instability.
  5. Patient requiring more than 2 intraoperative anastomosis

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm does not receive additional treatment and the procedure will be finished.
Experimental: HIPEC group
After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm receive a HIPEC procedure with cisplatin and doxorubicin.
Procedure: HIPEC
Following complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 1 year
To assess the mortality associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.
Up to 1 year
Morbility
Time Frame: Up to 1 year
To assess the morbidity associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.
Up to 1 year
Impact of quality of life
Time Frame: Up to 1 year
To evaluate the impact on patients' quality of life, which is undergoing intraperitoneal hyperthermic chemotherapy during interval laparotomy. The scales that will be used will be EORTC QLQ-C30 (Ver. 3) and EORTC QLQ-OV28.
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: Up to 2 years
Evaluate disease-free survival.
Up to 2 years
Overall survival
Time Frame: up to five years
Evaluate overall 5 year survival.
up to five years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Nacional de Cancerologia de Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rosa A Salcedo-Hernandez, MSc, Instituto Nacional de Cancerologia, Columbia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCAN/CI/483/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The database without any patient identity data could be accede for anyone asking for.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Ovarian Cancer

Clinical Trials on HIPEC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings