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

Peritoneal Carcinoma Clinical Trial

— HIPEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04415944
• Other study ID #: IRB00066278
• Secondary ID: WFBCCC 04619P30C
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Study Nurse
• Phone: 336-713-3539
• Email: arcarrol[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Ovarian Epithelial Cancer Stage I
• Ovarian Epithelial Cancer Stage II
• Ovarian Epithelial Cancer Stage III
• Peritoneal Carcinoma
• Stage I Fallopian Tube Cancer
• Stage II Fallopian Tube Cancer
• Stage III Fallopian Tube Cancer

Intervention

Procedure:
• Second look laparoscopy reassessment surgery (SLLRS)
Performed less than 12 weeks after intravenous chemotherapy cycles are completed.

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients To Succesfully 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.	Up to 3 months post treatment
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 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.	Up to 6 months post-treatment
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 adverse event. Mean, standard deviation, median, and interquartile range will be calculated for number of adverse events.	Up to 3 months post treatment