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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01045 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 83216 | Other Identifier | Wake Forest University Health Sciences | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well hyperthermic intraperitoneal chemotherapy works in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill any cancer cells left over after surgery.
PRIMARY OBJECTIVES:
I. To describe quality of life in patients with advanced ovarian cancer treated with standard of care (SOC) neoadjuvant chemotherapy (NAC) followed by cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) at 6 weeks post-treatment.
SECONDARY OBJECTIVES:
I. To describe quality of life in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC at 3 and 6 months post-treatment.
II. To describe neurotoxicity in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.
III. To describe abdominal discomfort in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.
IV. To describe toxicities in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.
V. To describe the response rate in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.
VI. To describe progression-free survival (PFS) in patients with advanced ovarian cancer treated with NAC followed by CRS with HIPEC.
OUTLINE: Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin intraperitoneally (IP) over 90 minutes immediately following CRS.
After completion of chemotherapy, patients are followed up at 30 days, and 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - Carboplatin, CRS, HIPEC | Experimental | Beginning 4-8 weeks after completion of chemotherapy, patients undergo CRS. Patients then receive carboplatin IP over 90 minutes immediately following CRS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Given IV and IP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) | 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. | At 6 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire | 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), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kelly | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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Enrollment period was January 2019 through December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | May 22, 2023 |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Cytoreductive Surgery | Procedure | Undergo CRS |
|
|
| Pre-treatment (baseline), 3 months after surgery, 6 months after surgery |
| Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | 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. | Up to 6 weeks post treatment |
| Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | 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). | Up to 6 months |
| Progression Free Survival | 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. | Up to 2 years from study enrollment |
| Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | 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. | At 3 months post treatment |
| Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | 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. | At 6 months post treatment |
| Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 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. | Up to 6 weeks post surgery |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Tumor Location | Count of Participants | Participants |
|
| 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 | Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O) | 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. | All participants did not have data collected for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At 6 weeks post treatment |
|
|
| |||||||||||||||||||||||||
| Secondary | Abdominal Discomfort Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Abdominal Discomfort Questionnaire | 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), | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (baseline), 3 months after surgery, 6 months after surgery |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Toxicities Reported (National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) | 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. | All participants able to receive the full protocol treatment. | Posted | Count of Participants | Participants | Up to 6 weeks post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Neurotoxicity Assessed Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival | 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. | All enrolled participants | Posted | Median | 95% Confidence Interval | months | Up to 2 years from study enrollment |
|
| ||||||||||||||||||||||||||
| Secondary | Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | 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. | Posted | Mean | Standard Deviation | score on a scale | At 3 months post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Quality of Life (QOL) in Patients With Advanced Ovarian Cancer Assessed Using Functional Assessment of Cancer Therapy-Ovarian (FACT-O) | 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. | Posted | Mean | Standard Deviation | score on a scale | At 6 months post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Response Rates Evaluated According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 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. | All participants who were able to complete all treatment according to protocol. | Posted | Count of Participants | Participants | Up to 6 weeks post surgery |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 6 | 50 | 27 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Atelaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Limb Edema | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Metabolic Acidosis | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator | Wake Forest Baptist Comprehensive Cancer Center | 3367135440 | Michael.G.Kelly@advocatehealth.org |
| Sep 11, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2023 | Jun 3, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D065426 | Cytoreduction Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
|
|
|
|
|
|
| Ten to Fourteen Adverse Events |
|
| Fifteen to Nineteen Adverse Events |
|
| Twenty or More Adverse Events |
|