Study on Feasibility and Quality of Life with Heated Chemotherapy During Second Look Surgery for Ovarian Cancer

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04415944

Provider View

This clinical trial is exploring whether it is possible and beneficial to use heated chemotherapy directly in the abdomen during a follow-up surgery for ovarian cancer patients, and how it affects their quality of life.

Patient Parameters

Program Overview

The aim of this study is to find out if using heated chemotherapy, known as hyperthermic intraperitoneal chemotherapy (HIPEC), during a follow-up surgery is feasible and safe for patients with ovarian cancer. The study will also monitor the effects, both good and bad, on the participants' health.

Description

The main goal of this study is to see if it is possible to perform a follow-up surgery called second look laparoscopy and use heated chemotherapy with a drug called carboplatin at the same time.

Secondary goals include:

  • Comparing the quality of life in ovarian cancer patients who have this surgery and heated chemotherapy with those who only have surgery and regular chemotherapy.
  • Describing any side effects experienced by patients who receive the heated chemotherapy during the follow-up surgery.

Study Process:

Participants will undergo a second look laparoscopy. If cancer is visible in the abdomen, they will also receive heated chemotherapy with carboplatin directly into the abdomen for 90 minutes, unless the disease progresses or side effects become unacceptable.

After completing the study treatment, participants will be monitored for up to 6 months to assess their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage I-III epithelial carcinoma of the ovary, fallopian tube, or peritoneum, or Stage IVA disease with complete resolution of disease after chemotherapy.
  • Have had surgery to remove as much of the cancer as possible and completed 3-8 cycles of platinum-based chemotherapy within the last 18 weeks.
  • Surgery must have removed all visible cancer or left only minimal disease before starting chemotherapy.
  • Low level of internal scarring (adhesion index less than 10).
  • No signs of cancer after chemotherapy, confirmed by exams, scans, and normal tumor markers (CA125).
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate blood cell counts and organ function based on specific medical tests.
  • Use effective contraception and have a negative pregnancy test if applicable.
  • Able to understand and willing to sign a consent form to participate.

Exclusion Criteria

  • More than 18 weeks since the last platinum-based chemotherapy.
  • Received additional chemotherapy for ovarian cancer after initial treatment.
  • Previous abdominal or pelvic radiation.
  • Extensive internal scarring noted during initial surgery (adhesion index greater than 10).
  • Abdominal infection from initial surgery requiring extended hospital stay or related to chemotherapy requiring hospitalization.
  • Allergic reactions to carboplatin or similar drugs.
  • Uncontrolled health issues like ongoing infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that affect participation.
  • Pregnancy.

Note: Men are not eligible due to the specific nature of the disease being studied.

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