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

Primary Purpose

Ovarian Epithelial Cancer Stage I, Ovarian Epithelial Cancer Stage II, Ovarian Epithelial Cancer Stage III

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Second look laparoscopy reassessment surgery (SLLRS)
HIPEC with Carboplatin
FACT-O Quality of Life Questionnaire
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer Stage I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 3-6 cycles of platinum-based systemic chemotherapy less than 12 weeks prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 12 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.[22] (See appendix)
  • 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 12 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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Second Look Laparoscopy and HIPEC with Carboplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 1, 2020
Last Updated
August 7, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04415944
Brief Title
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer Stage I, Ovarian Epithelial Cancer Stage II, Ovarian Epithelial Cancer Stage III, Stage I Fallopian Tube Cancer, Stage II Fallopian Tube Cancer, Stage III Fallopian Tube Cancer, Peritoneal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Second Look Laparoscopy and HIPEC with Carboplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Second look laparoscopy reassessment surgery (SLLRS)
Intervention Description
Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
Intervention Type
Drug
Intervention Name(s)
HIPEC with Carboplatin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
FACT-O Quality of Life Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
Description
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.
Time Frame
Up to 3 months post treatment
Secondary Outcome Measure Information:
Title
Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
Description
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.
Time Frame
Up to 6 months post-treatment
Title
Number of Reported Toxicities
Description
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.
Time Frame
Up to 3 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Nurse
Phone
336-713-3539
Email
arcarrol@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel S. Lentz, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Nurse
Phone
335-713-3539
Email
arcarrol@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Samuel S Lentz, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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