NCT03188432

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

Completed Phase 2 Results posted Last updated 21 October 2025

What this trial tests

Phase 2 trial testing Carboplatin in Stage IIIC Fallopian Tube Cancer in 50 participants. Completed in 8 February 2024.

Timeline

2 January 2019

Primary endpoint
31 January 2024

8 February 2024

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	2 January 2019
Primary completion	31 January 2024
Estimated completion	8 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Carboplatin (Carboplatin) — full drug profile →
• Quality-of-Life Assessment
• Questionnaire Administration
• Cytoreductive Surgery

Conditions studied

• Stage IIIC Fallopian Tube Cancer — all drugs for Stage IIIC Fallopian Tube Cancer →
• Stage IIIC Ovarian Cancer — all drugs for Stage IIIC Ovarian Cancer →
• Stage IIIC Primary Peritoneal Cancer — all drugs for Stage IIIC Primary Peritoneal Cancer →
• Stage IV Fallopian Tube Cancer — all drugs for Stage IV Fallopian Tube Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, female only, with Stage IIIC Fallopian Tube Cancer or Stage IIIC Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) Primary · 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.

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	116.32	± 25.37

Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire Secondary · 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

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	1.76	± 2.7

3 months after surgery

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	1.79	± 2.4

6 months after surgery

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	3.13	± 4.4

Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Secondary · 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.

Non-Serious Adverse Events

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	0
Treatment - Carboplatin, CRS, HIPEC	2
Treatment - Carboplatin, CRS, HIPEC	6
Treatment - Carboplatin, CRS, HIPEC	13

Serious Adverse Events

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	32
Treatment - Carboplatin, CRS, HIPEC	6
Treatment - Carboplatin, CRS, HIPEC	2
Treatment - Carboplatin, CRS, HIPEC	1

Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire Secondary · 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).

Baseline

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	33.92	± 8.7

6 weeks post surgery

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	33.51	± 9.25

3 months post surgery

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	35.59	± 8.61

6 months post surgery

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	33.38	± 10.01

Progression Free Survival Secondary · 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.

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	12.46	9.2 – 15.2

Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Secondary · 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.

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	126.11	± 20.25

Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Secondary · 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.

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	119.53	± 31.40

Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Secondary · 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 parti

Group	Value	95% CI
Treatment - Carboplatin, CRS, HIPEC	17
Treatment - Carboplatin, CRS, HIPEC	17
Treatment - Carboplatin, CRS, HIPEC	3
Treatment - Carboplatin, CRS, HIPEC	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 year post-surgery.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment - Carboplatin, CRS, HIPEC

Serious: 27/41 (66%)

Deaths: 6/50

Serious adverse events (27 terms)

Reaction	System	Treatment - Carboplatin, C…
Anemia	Blood and lymphatic system disorders	—
Platelet Count Decreased	Investigations	—
Abdominal Pain	Gastrointestinal disorders	—
Atelaxis	Respiratory, thoracic and mediastinal disorders	—
Hypotension	Vascular disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Intra-abdominal hemorrhage	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Small intestinal obstruction	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Death	General disorders	—
Fever	General disorders	—
Non-cardiac chest pain	General disorders	—
Urinary Tract Infection	Infections and infestations	—
Creatinine Increased	Investigations	—
Neutrophil Count Decreased	Investigations	—
Hypokalemia	Metabolism and nutrition disorders	—
Acute Kidney Injury	Renal and urinary disorders	—
Urinary Retention	Renal and urinary disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (44 terms — click to expand)

Reaction	System	Treatment - Carboplatin, C…
Anemia	Blood and lymphatic system disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Hypocalcemia	Metabolism and nutrition disorders	—
Platelet count decreased	Investigations	—
Fatigue	General disorders	—
Lymphocyte count decreased	Investigations	—
Hypokalemia	Metabolism and nutrition disorders	—
White blood cell decreased	Investigations	—
Hyponatremia	Metabolism and nutrition disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Neutrophil count decreased	Investigations	—
Hypertension	Vascular disorders	—
Hypomagnesemia	Metabolism and nutrition disorders	—
Sinus Tachycardia	Cardiac disorders	—
Alanine aminotransferase increased	Investigations	—
Dizziness	Nervous system disorders	—
Constipation	Gastrointestinal disorders	—
Pain	General disorders	—
Alkaline phosphatase increased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Back Pain	Musculoskeletal and connective tissue disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Limb Edema	General disorders	—
Leukocytes	Blood and lymphatic system disorders	—
Headache	Nervous system disorders	—
Dysuria	Renal and urinary disorders	—
Hypotension	Vascular disorders	—
Abdominal Distension	Gastrointestinal disorders	—
Ileus	Gastrointestinal disorders	—
Chills	General disorders	—
Urinary Tract Infection	Infections and infestations	—
Metabolic Acidosis	Investigations	—
Hypophosphatemia	Metabolism and nutrition disorders	—
Paresthesia	Nervous system disorders	—
Wound dehiscence	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Anemia, Platelet Count Decreased, Abdominal Pain, Atelaxis, Hypotension, Constipation, Diarrhea, Intra-abdominal hemorrhage.

Data from ClinicalTrials.gov NCT03188432 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraperitoneal chemotherapy for ovarian cancer with peritoneal metastases, systematic review of the literature and focused personal experience.
   Coccolini F, Fugazzola P, Montori G, Ansaloni L, et al · · 2021 · cited 17× · PMID 33968435 · DOI 10.21037/jgo-2020-06
2. Heated Intraperitoneal Chemotherapy in the Management of Advanced Ovarian Cancer.
   Jewell A, McMahon M, Khabele D. · · 2018 · cited 16× · PMID 30200420 · DOI 10.3390/cancers10090296