Trial Outcomes & Findings for Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT03188432)

Last Updated: 2025-10-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

At 6 weeks post treatment

Results posted on

2025-10-21

Participant Flow

Enrollment period was January 2019 through December 2023.

Participant milestones

Participant milestones
Measure	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. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Overall Study STARTED	50
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Overall Study Death	3
Overall Study Withdrawal by Subject	15
Overall Study Did not complete protocol treatment	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment - Carboplatin, CRS, HIPEC n=50 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Tumor Location Ovary	33 Participants n=5 Participants
Tumor Location Peritoneum	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 weeks post treatment

Population: All participants did not have data collected for this outcome measure.

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=30 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)	116.32 score on a scale Standard Deviation 25.37

SECONDARY outcome

Timeframe: Pre-treatment (baseline), 3 months after surgery, 6 months after surgery

Population: The most patients completed the survey at 6 months after surgery; most of them also completed the survey at baseline, and the fewest completed the survey at 3 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),

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=48 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire Pre-treatment	1.76 score on a scale Standard Deviation 2.7
Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire 3 months after surgery	1.79 score on a scale Standard Deviation 2.4
Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire 6 months after surgery	3.13 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: Up to 6 weeks post treatment

Population: All participants able to receive the full protocol 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.

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=41 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Non-Serious Adverse Events · Zero Adverse Events	0 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Non-Serious Adverse Events · One to Four Adverse Events	2 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Non-Serious Adverse Events · Five to Nine Adverse Events	6 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Non-Serious Adverse Events · Ten to Fourteen Adverse Events	13 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Non-Serious Adverse Events · Fifteen to Nineteen Adverse Events	11 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Non-Serious Adverse Events · Twenty or More Adverse Events	9 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Serious Adverse Events · Zero Adverse Events	32 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Serious Adverse Events · One to Four Adverse Events	6 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Serious Adverse Events · Five to Nine Adverse Events	2 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Serious Adverse Events · Ten to Fourteen Adverse Events	1 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Serious Adverse Events · Fifteen to Nineteen Adverse Events	0 Participants
Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) Serious Adverse Events · Twenty or More Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: 47 patients completed this survey at baseline, 27 at 6 weeks post-surgery, 22 at 3 months post-surgery and 19 at 6 months post-surgery.

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).

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=47 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire Baseline	33.92 score on a scale Standard Deviation 8.7
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire 6 weeks post surgery	33.51 score on a scale Standard Deviation 9.25
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire 3 months post surgery	35.59 score on a scale Standard Deviation 8.61
Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire 6 months post surgery	33.38 score on a scale Standard Deviation 10.01

SECONDARY outcome

Timeframe: Up to 2 years from study enrollment

Population: All enrolled participants

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.

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=50 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Progression Free Survival	12.46 months Interval 9.2 to 15.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=22 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)	126.11 score on a scale Standard Deviation 20.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=20 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O)	119.53 score on a scale Standard Deviation 31.40

SECONDARY outcome

Timeframe: Up to 6 weeks post surgery

Population: All participants who were able to complete all treatment according to protocol.

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.

Outcome measures

Outcome measures
Measure	Treatment - Carboplatin, CRS, HIPEC n=41 Participants Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Complete Reponse	17 Participants
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Partial Response	17 Participants
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Stable Disease	3 Participants
Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Progressive Disease	4 Participants

Adverse Events

Treatment - Carboplatin, CRS, HIPEC

Serious events: 27 serious events

Other events: 41 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Treatment - Carboplatin, CRS, HIPEC n=41 participants at risk Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Blood and lymphatic system disorders Anemia	12.2% 5/41 • Number of events 5 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Abdominal Pain	4.9% 2/41 • Number of events 2 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Constipation	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Diarrhea	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Intra-abdominal hemorrhage	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Nausea	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Small intestinal obstruction	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Vomiting	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Death	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Fever	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Non-cardiac chest pain	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Infections and infestations Urinary Tract Infection	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Creatinine Increased	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Neutrophil Count Decreased	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Platelet Count Decreased	9.8% 4/41 • Number of events 5 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hypokalemia	2.4% 1/41 • Number of events 2 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Renal and urinary disorders Acute Kidney Injury	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Renal and urinary disorders Urinary Retention	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Atelaxis	4.9% 2/41 • Number of events 2 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory Depression	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Vascular disorders Hypotension	4.9% 2/41 • Number of events 2 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Vascular disorders Thromboembolic Event	2.4% 1/41 • Number of events 1 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.

Other adverse events

Other adverse events
Measure	Treatment - Carboplatin, CRS, HIPEC n=41 participants at risk Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. Carboplatin: Given IV and IP Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Cytoreductive Surgery: Undergo CRS
Blood and lymphatic system disorders Anemia	92.7% 38/41 • Number of events 69 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Blood and lymphatic system disorders Leukocytes	12.2% 5/41 • Number of events 6 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Cardiac disorders Sinus Tachycardia	24.4% 10/41 • Number of events 10 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Abdominal Distension	9.8% 4/41 • Number of events 7 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Abdominal Pain	43.9% 18/41 • Number of events 21 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Constipation	17.1% 7/41 • Number of events 7 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Diarrhea	14.6% 6/41 • Number of events 6 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Ileus	9.8% 4/41 • Number of events 5 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Nausea	43.9% 18/41 • Number of events 26 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Gastrointestinal disorders Vomiting	43.9% 18/41 • Number of events 20 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Chills	9.8% 4/41 • Number of events 4 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Limb Edema	14.6% 6/41 • Number of events 7 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Fatigue	63.4% 26/41 • Number of events 38 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
General disorders Pain	17.1% 7/41 • Number of events 8 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Infections and infestations Urinary Tract Infection	9.8% 4/41 • Number of events 5 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Injury, poisoning and procedural complications Wound dehiscence	7.3% 3/41 • Number of events 3 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Alanine aminotransferase increased	19.5% 8/41 • Number of events 10 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Alkaline phosphatase increased	17.1% 7/41 • Number of events 8 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Aspartate aminotransferase increased	17.1% 7/41 • Number of events 8 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Lymphocyte count decreased	61.0% 25/41 • Number of events 37 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Metabolic Acidosis	9.8% 4/41 • Number of events 4 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Neutrophil count decreased	31.7% 13/41 • Number of events 17 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations Platelet count decreased	65.9% 27/41 • Number of events 48 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Investigations White blood cell decreased	53.7% 22/41 • Number of events 39 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Anorexia	17.1% 7/41 • Number of events 7 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hyperglycemia	85.4% 35/41 • Number of events 59 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hypoalbuminemia	43.9% 18/41 • Number of events 21 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hypocalcemia	73.2% 30/41 • Number of events 41 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hypokalemia	58.5% 24/41 • Number of events 35 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hypomagnesemia	26.8% 11/41 • Number of events 13 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hyponatremia	48.8% 20/41 • Number of events 32 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Metabolism and nutrition disorders Hypophosphatemia	9.8% 4/41 • Number of events 6 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Musculoskeletal and connective tissue disorders Back Pain	17.1% 7/41 • Number of events 8 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	7.3% 3/41 • Number of events 3 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Nervous system disorders Dizziness	19.5% 8/41 • Number of events 10 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Nervous system disorders Headache	12.2% 5/41 • Number of events 5 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Nervous system disorders Paresthesia	9.8% 4/41 • Number of events 4 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Nervous system disorders Peripheral sensory neuropathy	7.3% 3/41 • Number of events 3 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Psychiatric disorders Anxiety	7.3% 3/41 • Number of events 3 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Psychiatric disorders Confusion	7.3% 3/41 • Number of events 4 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Renal and urinary disorders Dysuria	12.2% 5/41 • Number of events 6 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	17.1% 7/41 • Number of events 8 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Vascular disorders Hypertension	29.3% 12/41 • Number of events 21 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.
Vascular disorders Hypotension	12.2% 5/41 • Number of events 6 • Up to 1 year post-surgery. Adverse event data were recorded with each cycle of chemotherapy, at the post-surgery visit, and at 6 weeks, 3, 6 and 12 months post-surgery. Adverse events were recorded only for those who completed the full protocol treatment (n=41), but all enrolled patients (n=50) were following for mortality, since all enrolled patients were at risk for mortality.

Additional Information

Principal investigator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 3367135440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place