Brief Title
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
Secondary Outcome
Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
Condition
Ovarian Epithelial Cancer Stage I
Intervention
Second look laparoscopy reassessment surgery (SLLRS)
Study Arms / Comparison Groups
Second Look Laparoscopy and HIPEC with Carboplatin
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
10
Start Date
May 20, 2021
Completion Date
September 2023
Primary Completion Date
July 2022
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 3-6 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Samuel S. Lentz, MD, 336-713-3539, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04415944
Organization ID
IRB00066278
Secondary IDs
WFBCCC 04619
Responsible Party
Sponsor
Study Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Samuel S. Lentz, MD, Principal Investigator, Wake Forest University Health Sciences
Verification Date
July 2021