HIPEC + Surgery for Ovarian Cancer
(CRS/HIPEC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on full-dose warfarin, you may need to maintain a specific blood test range. It's best to discuss your medications with the trial team.
Is the combination of HIPEC and surgery for ovarian cancer safe?
The combination of paclitaxel and carboplatin, used in ovarian cancer treatment, is generally considered safe but can cause side effects like neutropenia (low white blood cell count), neurotoxicity (nerve damage), and fatigue. Replacing cisplatin with carboplatin reduces neurotoxic effects, making the treatment better tolerated and suitable for outpatient care.12345
How does the HIPEC + Surgery treatment for ovarian cancer differ from other treatments?
The HIPEC + Surgery treatment for ovarian cancer is unique because it combines surgery with heated chemotherapy directly applied inside the abdomen, which has shown to significantly improve survival rates compared to other chemotherapy methods. This approach, using drugs like cisplatin and paclitaxel, is particularly effective for advanced stages of the disease.678910
What data supports the effectiveness of the treatment HIPEC + Surgery for Ovarian Cancer?
Research shows that combining cytoreductive surgery (removal of as much cancer as possible) with hyperthermic intraperitoneal chemotherapy (HIPEC, a heated chemotherapy treatment applied directly inside the abdomen) using drugs like cisplatin and paclitaxel can lead to favorable outcomes in treating advanced ovarian cancer.67101112
Who Is on the Research Team?
Armando Sardi, M.D.
Principal Investigator
Mercy Medical Center
Teresa Diaz-Montes, M.D., M.P.H
Principal Investigator
Mercy Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced stage (III/IV) ovarian, fallopian tube, or primary peritoneal cancer who haven't had treatment yet. They should be physically able to handle the procedures and have good organ function. Pregnant women, those with certain heart conditions, prior strokes or other cancers in the last 3 years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cytoreductive Surgery (CRS) with/without HIPEC
Participants undergo cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
Adjuvant Chemotherapy
Participants receive 6 cycles of adjuvant chemotherapy with either IV/IP or systemic IV combination chemotherapy
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adjuvant Chemotherapy
- Carboplatin
- Cisplatin
- Cytoreductive Surgery (CRS)
- Hyperthermic intraperitoneal chemotherapy
- Paclitaxel
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mercy Medical Center
Lead Sponsor