Trial Evaluating Feasibility and Quality of Life of Secon... | NCT04415944

ID	Type	Description	Link
WFBCCC 04619	Other Identifier	Wake Forest Baptist Comprehensive Cancer Center
P30CA012197	U.S. NIH Grant/Contract		View source

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Label	Type	Description	Intervention Names
Second Look Laparoscopy and HIPEC with Carboplatin	Experimental	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.	Procedure: Second look laparoscopy reassessment surgery (SLLRS) Drug: HIPEC with Carboplatin Other: FACT-O Quality of Life Questionnaire

Name	Type	Description	Arm Group Labels	Other Names
Second look laparoscopy reassessment surgery (SLLRS)	Procedure	Performed less than 12 weeks after intravenous chemotherapy cycles are completed.	Second Look Laparoscopy and HIPEC with Carboplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy	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.	end of treatment

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy
Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based systemic chemotherapy prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 18 weeks prior to second look surgery.
Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy
The intraoperative peritoneal adhesion index should be < 10.
Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy.
Age ≥ 18 years.
ECOG performance status ≤ 2.
Patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal
Adequate contraception and negative pregnancy test if pregnancy possible.
Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

Patients greater than 18 weeks from their last course of systemic platinum based chemotherapy
Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above.
Patients may not have received prior abdominal or pelvic radiation.
Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of >10 as defined above
Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
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.
Pregnancy

Men are excluded from participation due to the site-specific nature of the disease being studied.

Name	Affiliation	Role
Laurel Berry, MD	Wake Forest University Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest Baptist Comprehensive Cancer Center		Winston-Salem	North Carolina	27157	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 10, 2023

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG00010

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00010

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG00010

Title	Measurements
	BG00060.5± 7.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00010

Title	Measurements
Female	BG00010
Male

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00010

Title	Measurements
American Indian or Alaska Native	BG0000
Asian

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

- ParticipantsBG00010

Title	Measurements
	BG00010

FACT-O total score

FACT-O is a measure of quality of life. 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.

One patient did not complete the FACT-O QoL survey prior to treatment

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

- ParticipantsBG0009

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy

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.

Posted

Count of Participants

Participants

end of treatment

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00010

Title

Denominators

Categories

Title	Measurements
	OG00010

Secondary

Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire

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.

Missing data due to participant drop-out/refusal leaves n=5 @ 3 months and n=4 @ 6 months.

Posted

Mean

Standard Deviation

score on a scale

Up to 6 months post-treatment

ID	Title	Description
OG000	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.

Secondary

Number of Reported Toxicities

Toxicities 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.

Posted

Number

participants

Up to 3 months post treatment

ID	Title	Description
OG000	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	10	1	10	10	10

Term	Organ System	Assessment Type	Statistical Information
Neutrophil count decreased	Investigations	Systematic Assessment	EG0001 events1 affected10 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0002 events1 affected10 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG0001 events1 affected10 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00017 events9 affected10 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0006 events4 affected10 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 events2 affected10 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0009 events6 affected10 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected10 at risk
Edema limbs	General disorders and administration site conditions	Systematic Assessment	EG0002 events1 affected10 at risk
Fatigue	General disorders and administration site conditions	Systematic Assessment	EG0004 events2 affected10 at risk
Pain	General disorders and administration site conditions	Systematic Assessment	EG0005 events4 affected10 at risk
Bruising	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected10 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0004 events3 affected10 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 events1 affected10 at risk
Blood bicarbonate decreased	Investigations	Systematic Assessment	EG0001 events1 affected10 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG00011 events6 affected10 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0005 events4 affected10 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0008 events4 affected10 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG00013 events5 affected10 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 events7 affected10 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events2 affected10 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0005 events4 affected10 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 events3 affected10 at risk
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events1 affected10 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events2 affected10 at risk
Metabolism and nutrition disorders - Other: Total Serum Protein decreased	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Muscle cramp	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Absolute Neutrophil count increased	Investigations	Systematic Assessment	EG0001 events1 affected10 at risk
Drowsiness	General disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Urinary frequency	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected10 at risk
Hematoma	Vascular disorders	Systematic Assessment	EG0002 events1 affected10 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0003 events1 affected10 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected10 at risk

ID	Term
D000077216	Carcinoma, Ovarian Epithelial
D005185	Fallopian Tube Neoplasms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D010051	Ovarian Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases

ID	Term
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D006979	Hyperthermia, Induced
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Term
D000084262	Hyperthermic Intraperitoneal Chemotherapy
D016190	Carboplatin