Phase 2
N=50
Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer · Stage IIIC Ovarian Cancer · Stage IIIC Primary Peritoneal Cancer · Stage IV Fallopian Tube Cancer · Stage IV Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03188432 ↗Enrolled (actual)
50
Serious AEs
65.9%
Results posted
Oct 2025
Primary outcome: Primary: Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) — 116.32 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Cytoreductive Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) |
116.32 | — |
| SECONDARY Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire |
1.76; 1.79; 3.13 | — |
| SECONDARY Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) |
0; 2; 6; 13; 11; 9 | — |
| SECONDARY Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire |
33.92; 33.51; 35.59; 33.38 | — |
| SECONDARY Progression Free Survival |
12.46 | — |
| SECONDARY Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) |
126.11 | — |
| SECONDARY Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) |
119.53 | — |
| SECONDARY Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
17; 17; 3; 4 | — |
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. 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.
Eligibility Criteria
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 = = 1,500/mcL (within 30 days of registration)
- Platelets >= 75, 000/mcL (within 30 days of registration)
- Total bilirubin = = 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.
Data sourced from ClinicalTrials.gov (NCT03188432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.