Trial Outcomes & Findings for Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy (NCT NCT04415944)
NCT ID: NCT04415944
Last Updated: 2026-08-10
Results Overview
The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
end of treatment
Results posted on
2026-08-10
Participant Flow
Participant milestones
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient did not complete the FACT-O QoL survey prior to treatment
Baseline characteristics by cohort
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
n=10 Participants
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=10 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 7.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
|
FACT-O total score
|
123.4 units on a scale
STANDARD_DEVIATION 16.2 • n=9 Participants • One patient did not complete the FACT-O QoL survey prior to treatment
|
PRIMARY outcome
Timeframe: end of treatmentThe proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.
Outcome measures
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
n=10 Participants
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
|
|---|---|
|
Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months post-treatmentPopulation: Missing data due to participant drop-out/refusal leaves n=5 @ 3 months and n=4 @ 6 months.
The quality of life in patients with advanced ovarian cancer after undergoing second look laparoscopy reassessment surgery with hyperthermic intraperitoneal chemotherapy using Carboplatin (CBDCA) will be determined by the FACT-O questionnaire at pre-study, and months 3, and 6 in follow-up (post-treatment). The distribution of quality of life at each visit will be examined and the descriptive statistics will be presented. Scoring scale - (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much) and includes questions relating to Physical Well-Being (7 items), Social Well-being (7 items), Functional Well-Being (7 items), Emotional Well-Being (6 items) and Additional Ovarian Cancer Concerns (12-item). Scores could range from 0-156. Higher scores are associated with better QOL.
Outcome measures
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
n=5 Participants
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
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|---|---|
|
Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
FACT-O total score at 3 months
|
137.4 score on a scale
Standard Deviation 9.9
|
|
Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
FACT-O total score at 6 months
|
137.3 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Up to 3 months post treatmentToxicities will be indicated by the number and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Counts and percentages will be calculated for each organ system. Only the most severe cases of each organ system will be counted in the summary.
Outcome measures
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
n=10 Participants
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
|
|---|---|
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Number of Reported Toxicities
General disorders and administration site conditions grade 1-2
|
5 participants
|
|
Number of Reported Toxicities
Renal and urinary disorders grade 1-2
|
2 participants
|
|
Number of Reported Toxicities
Blood and lymphatic system disorders grade 1-2
|
8 participants
|
|
Number of Reported Toxicities
Blood and lymphatic system disorders grade 3-4
|
1 participants
|
|
Number of Reported Toxicities
Gastrointestinal disorders grade 1-2
|
8 participants
|
|
Number of Reported Toxicities
Gastrointestinal disorders grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
General disorders and administration site conditions grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Injury, poisoning and procedural complications grade 1-2
|
1 participants
|
|
Number of Reported Toxicities
Injury, poisoning and procedural complications grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Investigations grade 1-2
|
5 participants
|
|
Number of Reported Toxicities
Investigations grade 3-4
|
5 participants
|
|
Number of Reported Toxicities
Metabolism and nutrition disorders grade 1-2
|
8 participants
|
|
Number of Reported Toxicities
Metabolism and nutrition disorders grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Musculoskeletal and connective tissue disorders grade 1-2
|
2 participants
|
|
Number of Reported Toxicities
Musculoskeletal and connective tissue disorders grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Nervous system disorders grade 1-2
|
1 participants
|
|
Number of Reported Toxicities
Nervous system disorders grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Renal and urinary disorders grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Reproductive system and breast disorders grade 1-2
|
1 participants
|
|
Number of Reported Toxicities
Reproductive system and breast disorders grade 3-4
|
0 participants
|
|
Number of Reported Toxicities
Vascular disorders grade 1-2
|
3 participants
|
|
Number of Reported Toxicities
Vascular disorders grade 3-4
|
1 participants
|
Adverse Events
Second Look Laparoscopy and HIPEC With Carboplatin
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
n=10 participants at risk
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
|
|---|---|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 2 • During treatment and up to 6 months post treatment.
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
Other adverse events
| Measure |
Second Look Laparoscopy and HIPEC With Carboplatin
n=10 participants at risk
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
Second look laparoscopy reassessment surgery (SLLRS): Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
HIPEC with Carboplatin: Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
Patients who exhibit the following will not receive the HIPEC procedure:
* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.
FACT-O Quality of Life Questionnaire: Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
|
|---|---|
|
Investigations
Absolute Neutrophil count increased
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
General disorders
Drowsiness
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Vascular disorders
Hematoma
|
10.0%
1/10 • Number of events 2 • During treatment and up to 6 months post treatment.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 3 • During treatment and up to 6 months post treatment.
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • Number of events 2 • During treatment and up to 6 months post treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
9/10 • Number of events 17 • During treatment and up to 6 months post treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
4/10 • Number of events 6 • During treatment and up to 6 months post treatment.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 3 • During treatment and up to 6 months post treatment.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 9 • During treatment and up to 6 months post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2 • During treatment and up to 6 months post treatment.
|
|
General disorders and administration site conditions
Edema limbs
|
10.0%
1/10 • Number of events 2 • During treatment and up to 6 months post treatment.
|
|
General disorders and administration site conditions
Fatigue
|
20.0%
2/10 • Number of events 4 • During treatment and up to 6 months post treatment.
|
|
General disorders and administration site conditions
Pain
|
40.0%
4/10 • Number of events 5 • During treatment and up to 6 months post treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
3/10 • Number of events 4 • During treatment and up to 6 months post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Investigations
Blood bicarbonate decreased
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Investigations
Lymphocyte count decreased
|
60.0%
6/10 • Number of events 11 • During treatment and up to 6 months post treatment.
|
|
Investigations
Neutrophil count decreased
|
40.0%
4/10 • Number of events 5 • During treatment and up to 6 months post treatment.
|
|
Investigations
Platelet count decreased
|
40.0%
4/10 • Number of events 8 • During treatment and up to 6 months post treatment.
|
|
Investigations
White blood cell decreased
|
50.0%
5/10 • Number of events 13 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.0%
7/10 • Number of events 10 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
2/10 • Number of events 3 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
40.0%
4/10 • Number of events 5 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
3/10 • Number of events 4 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 2 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 3 • During treatment and up to 6 months post treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other: Total Serum Protein decreased
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • During treatment and up to 6 months post treatment.
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 13367166672
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place