Stage IIIC Fallopian Tube CancerPhase 2NCT03188432
Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study testing Carboplatin, Quality-of-Life Assessment and Questionnaire Administration in people with Stage IIIC Fallopian Tube Cancer and Stage IIIC Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer
- What is being tested?
- Carboplatin, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 8 Feb 2024
- 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 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):
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer
- Being tested
- Carboplatin, Quality-of-Life Assessment, Questionnaire Administration, Cytoreductive Surgery
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV and IP
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Cytoreductive SurgeryProcedure or surgery
Also called Operation, Surgery, Surgical, Surgical Interventions
Undergo CRS
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Experimental | Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Receives: Drug: Carboplatin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Cytoreductive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)
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.
Measured: At 6 weeks post treatment
Secondary outcomes (7)
Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire
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),
Measured: 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)
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.
Measured: Up to 6 weeks post treatment
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire
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).
Measured: Up to 6 months
Progression Free Survival
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.
Measured: Up to 2 years from study enrollment
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
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.
Measured: 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)
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.
Measured: At 6 months post treatment
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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.
Measured: Up to 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start2 Jan 2019
- Primary completion31 Jan 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage IIIC Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Kelly, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188432
- Sponsor's protocol ID
- IRB00044434
- Other IDs
- NCI-2017-01045, CCCWFU 83216, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2017
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Comparing Quality of Life After HIPEC in Patients With Stage IIIC and IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT03188432
- Acronym / sponsor ID
- IRB00044434
- Conditions
- Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 21 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Experimental | Drug: Carboplatin, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Cytoreductive SurgeryBeginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV and IP | Drug | Treatment - Carboplatin, CRS, HIPEC |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment - Carboplatin, CRS, HIPEC |
| Questionnaire AdministrationAncillary studies | Other | Treatment - Carboplatin, CRS, HIPEC |
| Cytoreductive SurgeryAlso: Operation, Surgery, Surgical, Surgical InterventionsUndergo CRS | Procedure or surgery | Treatment - Carboplatin, CRS, HIPEC |
Primary outcome
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.
7 secondary outcomes
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
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
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire
Time frame: Up to 6 months
Progression Free Survival
Time frame: 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
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
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 6 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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RecruitingPhase 3
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
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Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
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TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kelly principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Quality-of-Life Assessment and Questionnaire Administration in people with Stage IIIC Fallopian Tube Cancer and Stage IIIC Ovarian Cancer, 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 14 inclusion and 6 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 21 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 21 Oct 2025). 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?
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) (time frame: At 6 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.