COMPLETED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-05-20

Study Completion:2026-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04415944

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Laurel Berry, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Laurel Berry, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-20

Study Completion Date2026-01-23

Study Record Updates

Study Start Date2021-05-20

Study Completion Date2026-01-23

Terms related to this study

Additional Relevant MeSH Terms

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