Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

October 2, 2025 updated by: Wake Forest University Health Sciences

A Phase II Trial Comparing Quality of Life After HIPEC in Patients With Stage IIIC and IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

This phase II trial studies how well hyperthermic intraperitoneal chemotherapy works in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill any cancer cells left over after surgery.

Study Overview

Status

Status

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

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

PRIMARY OBJECTIVES:

I. To describe quality of life in patients with advanced ovarian cancer treated with standard of care (SOC) neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) at 6 weeks post-treatment.

SECONDARY OBJECTIVES:

I. To describe quality of life in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC at 3 and 6 months post-treatment.

II. To describe neurotoxicity in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

III. To describe abdominal discomfort in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

IV. To describe toxicities in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

V. To describe the response rate in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

VI. To describe progression-free survival (PFS) in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.

OUTLINE: Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin intraperitoneally (IP) over 90 minutes immediately following CRS.

After completion of chemotherapy, patients are followed up at 30 days, and 3, 6, and 12 months.

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 (Actual)

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.
50

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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed non-mucinous, epithelial stage 3 or 4 carcinoma of the ovary, fallopian tube or peritoneum.
  • Patients must not have received treatment for another malignancy within 3 years of enrollment (patients who have received hormone therapy within 3 years of enrollment are still eligible).
  • Patients must have received at least 3 but not more than 6 cycles of carboplatin-doublet based IV neoadjuvant chemotherapy and achieved at least stable disease (radiographically confirmed) at the conclusion of this therapy.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patients must have adequate organ and marrow function as defined below (within 30 days of registration):
  • Absolute neutrophil count >= 1,500/mcL (within 30 days of registration)
  • Platelets >= 75,000/mcL (within 30 days of registration)
  • Total bilirubin =< 1.5 mg/dL (within 30 days of registration)
  • Creatinine clearance >= 50 mg/dL (within 30 days of registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal (within 30 days of registration)
  • Alkaline phosphatase =< 3 x institutional upper limit of normal (within 30 days of registration)
  • The effects of HIPEC on the developing human fetus are unknown. For this reason, and because carboplatin doublet therapy consists of pregnancy category D agents, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents.
  • Patients with extra-abdominal metastatic disease.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin doublet agents.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because carboplatin doublet therapy consists of pregnancy category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin doublet therapy, breastfeeding should be discontinued.
  • Men are excluded from participating due to the site specific nature of the disease being studied.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: Treatment - Carboplatin, CRS, HIPEC
Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Cytoreductive Surgery
Undergo CRS
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Interventions
  • Surgical Procedures
  • Surgical Procedure
Drug: Carboplatin
Given IV and IP
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

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
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)
Time Frame: At 6 weeks post treatment

This is a descriptive study. QOL will be measured using the Fact-O questionnaire and treated as a continuous outcome. The distribution of QOL at 6 weeks post-treatment will be examined. Descriptive statistics such as mean, standard deviation, median and interquartile range will be calculated.

The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.
At 6 weeks post treatment

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
Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire
Time Frame: Pre-treatment (baseline), 3 months after surgery, 6 months after surgery

To describe abdominal discomfort at up to 3 times points during the study, descriptive statistics will be calculated and presented based on a 4-item score from FACT-GOG/AD. Counts and percentages will be calculated. Mean and standard deviation also will be calculated. This approach will be treated as a sensitivity analysis.

The Abdominal Discomfort section of the FACT-O uses 4 questions with five-point Likert Scales (0-4). The possible range of scores is 0-16, and higher scores indicate a better quality of life (less discomfort),
Pre-treatment (baseline), 3 months after surgery, 6 months after surgery
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)
Time Frame: Up to 6 weeks post treatment
The toxicities will be measured by the number and severity of adverse events defined by CTCAE version 5.0. Counts and percentages will be calculated for each type of adverse event. The counts were grouped in the table below. A particular count might include several occurrences of the same event (eg, anemia) or one occurrence of several different events.
Up to 6 weeks post treatment
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire
Time Frame: Up to 6 months
Neurotoxicity at up to three time points in the study will be described. The neurotoxicity subscale is an 11-item measure from FACT/GOG-NTX. The possible range of scores is 0 to 44, with higher scores indicating lower quality of life (more neurotoxicity).
Up to 6 months
Progression Free Survival
Time Frame: Up to 2 years from study enrollment
Progression free survival will be estimated using Kaplan-Meier methods, using the time from the study registration up to date of progression, date of last contact, or death, whichever comes first.
Up to 2 years from study enrollment
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Time Frame: At 3 months post treatment

The distribution of QOL based on the Fact-O questionnaire at 3 months post-treatment will be examined. The descriptive statistics of QOL at 3 months post-treatment will be presented.

The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.
At 3 months post treatment
Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Time Frame: At 6 months post treatment

The distribution of QOL based on the Fact-O questionnaire at 6 months post-treatment will be examined. The descriptive statistics of QOL at 6 months post-treatment will be presented.

The FACT-O consists of 39 questions answered with five-point Likert Scales (0-4). The possible range of scores is 0-156, and higher scores indicate a better quality of life.
At 6 months post treatment
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame: Up to 6 weeks post surgery
The best overall response using RECIST criteria will be determined for each evaluable patient and proportions achieving a complete or partial response will be estimated with 95% confidence intervals. Complete response means all target lesions have disappeared; partial response requires at least a 30% decrease in the sum of the longest diameters of target lesions from baseline. Progressive disease is defined by a 20% increase in the sum of the longest diameters of target lesions or the appearance of new lesions. Stable disease is defined as the absence of sufficient changes to qualify for partial response or progressive disease.
Up to 6 weeks post surgery

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.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

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: Michael Kelly, Wake Forest University Health Sciences

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.
January 2, 2019

Primary Completion (Actual)

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.
January 31, 2024

Study Completion (Actual)

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.
February 8, 2024

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).
June 13, 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.
June 13, 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.
June 15, 2017

Study Record Updates

Last Update Posted (Estimated)

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.
October 21, 2025

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.
October 2, 2025

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.
October 1, 2025

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.
  • IRB00044434
  • P30CA012197 (U.S. NIH Grant/Contract)
  • NCI-2017-01045 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 83216 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

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