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HIPEC + Surgery for Ovarian Cancer (CRS/HIPEC Trial)
CRS/HIPEC Trial Summary
This trial is testing whether a surgery to remove as much of the cancer as possible, followed by a heated chemotherapy treatment, is a safe and effective treatment for ovarian, fallopian tube, and primary peritoneal cancer.
CRS/HIPEC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCRS/HIPEC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CRS/HIPEC Trial Design
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Who is running the clinical trial?
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- I am currently on IV antibiotics for an infection.I had a heart attack or other heart issue in the last 6 months.I have moderate to severe heart failure.My kidney function is reduced with high creatinine or low clearance.I have had a stroke or brain artery disease in the last 6 months.My blood pressure is higher than 140/90 and I haven't been cleared for surgery by a heart doctor.I am not pregnant or breastfeeding.My condition is in stage III or IV.I haven't had treatment or major surgery for ovarian, fallopian tube, or peritoneal cancer, but diagnostic laparoscopy is okay.My health allows me to receive chemotherapy after surgery.I have active hepatitis and HIV.I experience chest pain with normal physical activity.I am mostly self-sufficient and can carry out daily activities.My blood tests show normal white blood cells, platelets, and hemoglobin levels.You are expected to live less than 12 weeks.I have had surgery to remove as much of the cancer as possible.I have had treatment for ovarian, fallopian tube, or peritoneal cancer.Your blood clotting tests should be within normal range, and if you are taking warfarin, your blood thinning levels should be in a specific range.Confirmation through tissue sample testing.I have not had any other cancer in the last 3 years.My kidney function is within the normal range.My cancer is in the early stages (Stage I or II).After surgery to remove as much cancer as possible, less than 1 cm of cancer remains.My cancer originates from the ovary, fallopian tube, or peritoneum.My liver tests are within the required range.
- Group 1: CRS with adjuvant IV/IP chemotherapy
- Group 2: CRS/HIPEC with adjuvant IV chemotherapy
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the FDA recognize Hyperthermic intraperitoneal chemotherapy as an accepted treatment?
"Hyperthermic intraperitoneal chemotherapy is at a Phase 2, meaning that while there is safety data, there is no information yet on whether it works. Our team rates it as a 2."
Can new patients still join this clinical trial?
"Yes, this study is still recruiting patients as of 8/30/2022 according to the clinicaltrials.gov website. The trial was initially posted on 4/1/2014."
Does this experiment have an age limit? Can elderly persons participate?
"The age criteria for this study stipulate that patients must be over 18 but under 80 years old."
Who meets the eligibility requirements for this research?
"Eligibility criteria for this ovarian cancer clinical trial are being between 18-80 years old. They aim to recruit 48 patients in total."
What is the most common reason that patients receive hyperthermic intraperitoneal chemotherapy?
"Hyperthermic intraperitoneal chemotherapy is a well-known treatment for advanced endometrial cancer. Other conditions that this method can be used to treat include melanoma, neoplasm metastasis, lymphoma, and non-hodgkin."
How many people are participating in this clinical trial?
"That is correct, the clinical trial referenced is actively recruiting patients according to information found on clinicaltrials.gov. The original posting was on April 1st, 2014 with the most recent update being on August 30th, 2022. There is a need for 48 patients at a single location."
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