Study on HIPEC as Initial Treatment for Advanced Ovarian Cancer

Sponsor: Mercy Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT02124421

Provider View

This clinical trial is exploring the safety of combining surgery with a heated chemotherapy treatment called HIPEC for patients newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer.

Patient Parameters

Program Overview

The study aims to evaluate if combining surgery with a heated chemotherapy treatment called HIPEC is safe for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Researchers want to see if this combination can be safely added to the standard treatment plan, which usually involves surgery followed by chemotherapy.

Description

This study is divided into two groups to compare different treatment approaches for advanced ovarian, fallopian tube, or primary peritoneal cancer.

In one group, patients will undergo surgery to remove as much of the cancer as possible, followed by a heated chemotherapy treatment called HIPEC. Afterward, they will receive standard chemotherapy with carboplatin and paclitaxel through an IV for six cycles.

In the other group, patients will have surgery without the heated chemotherapy. They will then receive a combination of chemotherapy drugs, cisplatin and paclitaxel, both through an IV and directly into the abdomen (IP) for six cycles.

The study will assess how well patients tolerate these treatments, the rate of complications, and how long patients remain free of cancer after treatment. Researchers will also evaluate the overall survival rates at 1, 3, and 5 years and the impact on patients' quality of life.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (Stage III/IV).
  • No prior treatment or major surgery for these cancers, except for diagnostic procedures.
  • Cancer confirmed by lab tests.
  • Good overall health with a performance status score of 0-2.
  • Cancer reduced to 1 cm or less after surgery.
  • Adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1,000/mm3.
    • Platelet count of at least 100,000/mm3.
    • Hemoglobin level of at least 8.5 g/dL.
    • Normal kidney and liver function as indicated by specific blood tests.
    • Normal blood clotting times unless on stable anticoagulation.
  • Eligible for standard chemotherapy after surgery.

Exclusion Criteria

  • Previous treatment for ovarian, fallopian tube, or primary peritoneal cancer.
  • Early-stage cancer (Stage I/II).
  • Other invasive cancers or cancer within the past 3 years.
  • Active hepatitis or HIV infection.
  • Severe infections requiring IV antibiotics.
  • Recent heart problems, such as heart attacks or severe heart failure.
  • Uncontrolled high blood pressure.
  • Recent stroke or severe artery disease.
  • Poor kidney function.
  • Severe unrelated medical conditions.
  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Life expectancy of less than 12 weeks.

Locations

FACILITYZIPCITYSTATE
Mercy Medical Center21202BaltimoreMaryland

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