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

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.

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

Start Date

June 17, 2020

Completion Date

September 2022

Primary Completion Date

July 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian
             tube or peritoneum

          -  Patients must have undergone cytoreductive surgery and 3-6 cycles of platinum-based
             systemic chemotherapy < 12 weeks prior to the 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

March 2021