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Ovarian Neoplasms

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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.

Performed less than 12 weeks after intravenous chemotherapy cycles are completed.

Second look laparoscopy reassessment surgery (SLLRS)

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.

HIPEC with Carboplatin

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.

FACT-O Quality of Life Questionnaire

Study Nurse

Laurel Berry, MD

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic intraperitoneal chemotherapy with carboplatin.

Secondary Objective(s)

* To compare the quality if life in patients with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in patients treated with cytoreduction surgery and systemic chemotherapy alone.
* To describe toxicities in patients with ovarian cancer treated with second look laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.

OUTLINE:

Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 6 months.

Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

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.

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 and the distribution of change in quality of life at each follow-up 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.

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 adverse event. Mean, standard deviation, median, and interquartile range will be calculated for number of adverse events.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy	NCT04415944	Ovarian Epithel... Ovarian Epithel... Ovarian Epithel... Stage I Fallopi... Stage II Fallop... Stage III Fallo... Peritoneal Carc...	Second look lap... HIPEC with Carb... FACT-O Quality ...	18 Years -	Wake Forest University Health Sciences
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy	NCT04415944	Ovarian Epithel... Ovarian Epithel... Ovarian Epithel... Stage I Fallopi... Stage II Fallop... Stage III Fallo... Peritoneal Carc...	Second look lap... HIPEC with Carb... FACT-O Quality ...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for ovarian epithelial cancer stage ii