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Ovarian Epithelial Cancer Stage IPhase 2HIPECNCT04415944

Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

A Phase 2 study testing Second look laparoscopy reassessment surgery (SLLRS), HIPEC with Carboplatin and FACT-O Quality of Life Questionnaire in people with Ovarian Epithelial Cancer Stage I and Ovarian Epithelial Cancer Stage II, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Second look laparoscopy reassessment surgery (SLLRS), HIPEC with Carboplatin and FACT-O Quality of Life Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
20 May 2021to 23 Jan 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy
  • Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based systemic chemotherapy prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 18 weeks prior to second look surgery.
  • Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy
  • The intraoperative peritoneal adhesion index should be < 10.
  • Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy.
  • Age ≥ 18 years.
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  • 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; platelets >100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal
  • Adequate contraception and negative pregnancy test if pregnancy possible.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document.

Who cannot join

  • Patients greater than 18 weeks from their last course of systemic platinum based chemotherapy
  • Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above.
  • Patients may not have received prior abdominal or pelvic radiation.
  • Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of >10 as defined above
  • Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
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  • 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.
  • Pregnancy
  • Men are excluded from participation due to the site-specific nature of the disease being studied.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Read the detailed description

Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic intraperitoneal chemotherapy with carboplatin.

Secondary Objective(s)

  • To compare the quality of life in participants with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in participants treated with cytoreduction surgery and systemic chemotherapy alone.
  • To describe toxicities in participants with ovarian cancer treated with second look laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.

OUTLINE:

Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 6 months.

Being tested
Second look laparoscopy reassessment surgery (SLLRS), HIPEC with Carboplatin, FACT-O Quality of Life Questionnaire
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Second look laparoscopy reassessment surgery (SLLRS)Procedure or surgery

    Performed less than 12 weeks after intravenous chemotherapy cycles are completed.

  • HIPEC with CarboplatinDrug

    Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.

    Patients who exhibit the following will not receive the HIPEC procedure:

    • Extraperitoneal disease noted at the time of the second look procedure
    • Macroscopic intraperitoneal disease which is not resectable to R1
    • Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
    • Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC

    Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.

  • FACT-O Quality of Life QuestionnaireOther

    Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.

Study groups in NCT04415944
Study groupRoleWhat they receive
Second Look Laparoscopy and HIPEC with CarboplatinExperimentalLaparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Receives: Procedure: Second look laparoscopy reassessment surgery (SLLRS); Drug: HIPEC with Carboplatin; Other: FACT-O Quality of Life Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy

    The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.

    Measured: end of treatment

Secondary outcomes (2)

  1. Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire

    The quality of life in patients with advanced ovarian cancer after undergoing second look laparoscopy reassessment surgery with hyperthermic intraperitoneal chemotherapy using Carboplatin (CBDCA) will be determined by the FACT-O questionnaire at pre-study, and months 3, and 6 in follow-up (post-treatment). The distribution of quality of life at each visit will be examined and the descriptive statistics will be presented. Scoring scale - (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much) and includes questions relating to Physical Well-Being (7 items), Social Well-being (7 items), Functional Well-Being (7 items), Emotional Well-Being (6 items) and Additional Ovarian Cancer Concerns (12-item). Scores could range from 0-156. Higher scores are associated with better QOL.

    Measured: Up to 6 months post-treatment

  2. Number of Reported Toxicities

    Toxicities will be indicated by the number and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Counts and percentages will be calculated for each organ system. Only the most severe cases of each organ system will be counted in the summary.

    Measured: Up to 3 months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start20 May 2021
  3. Primary completion19 Sep 2025
  4. Study completion23 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04415944
Sponsor's protocol ID
IRB00066278
Other IDs
WFBCCC 04619, P30CA012197
Acronym
HIPEC
Status last verified
Jul 2026
First submitted
1 Jun 2020
Last updated
10 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Second look laparoscopy reassessment surgery (SLLRS), HIPEC with Carboplatin and FACT-O Quality of Life Questionnaire in people with Ovarian Epithelial Cancer Stage I and Ovarian Epithelial Cancer Stage II, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy (time frame: end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04415944.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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