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PIPAC for Peritoneal Cancer
Study Summary
This trial is testing the side effects of a new way to give chemotherapy to patients with cancer that has spread to the lining of their abdominal cavity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am on exclusive IV nutrition for my colorectal/appendiceal condition.I haven't had chemotherapy, surgery, or certain cancer drugs for the required waiting period before joining.You had a severe allergic reaction to the chemotherapy drug used in the past.Your platelet count is at least 100,000 per cubic millimeter.I am immunocompromised due to medication or a known immune system disease.I am on exclusive IV nutrition for my colorectal or appendiceal condition.I have side effects from cancer treatment, but they are mild except for possible nerve pain.I need a tube for feeding due to a blocked intestine.I have severe heart issues or have been hospitalized for COPD or diabetes complications recently.Your hemoglobin level is at least 9 grams per deciliter.My peritoneal disease is visible on scans or through a diagnostic procedure.I do not have severe heart, kidney, liver issues, or infections that are not under control.I am not taking any experimental cancer treatments.I have had aerosol chemotherapy for colorectal or appendiceal cancer.Your alkaline phosphatase level is not more than twice the normal upper limit.I can take care of myself and am up and about more than half of my waking hours.I have a known DPD deficiency.I have a known DPD deficiency.You had a severe allergic reaction to the chemotherapy drug used in the past.I have received the highest safe dose of certain chemotherapy drugs for my ovarian, uterine, or gastric cancer.I have a blockage in my intestines that needs a tube for feeding or relief.I needed lower doses of chemotherapy due to blood-related side effects.I have not taken antibiotics for a major infection within 72 hours before my first dose of the study drug.I am eligible for PIPAC based on laparoscopy findings, with no major bowel issues, less than 5L of ascites, and not suitable for cytoreduction and HIPEC.I am using effective birth control or my partner is sterile.I have had aerosol chemotherapy for colorectal or appendiceal cancer.I have fluid in my abdomen due to liver issues and a blood clot in the liver's vein.I have tried at least one chemotherapy and my cancer has gotten worse.My doctor expects I have less than 6 months to live due to my colorectal/appendiceal cancer.My doctor expects I have less than 6 months to live due to my colorectal/appendiceal cancer.I couldn't tolerate previous treatments for my colorectal/appendiceal cancer due to severe side effects.I have previously received chemotherapy through injection into the abdomen.My cancer is in the ovary, uterus, stomach, appendix, or colon and has spread to the lining of my abdomen.Your absolute neutrophil count is at least 1500 per cubic millimeter.I am having surgery to remove a tumor and part of my digestive tract at the same time.I have fluid in my abdomen due to liver issues and a blood clot in the liver vein.My liver function tests are within the required range.I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.My stomach or colorectal cancer has spread beyond the abdominal lining.I had a severe allergic reaction to platinum-based cancer drugs.My colorectal/appendiceal cancer has worsened after the first two treatments.I can safely undergo a laparoscopy.I am having surgery to remove a tumor and part of my digestive tract at the same time.You have a mental illness or social situation that would make it hard for you to follow the study rules.I do not have severe heart, kidney, liver issues, or uncontrolled infections.I have severe heart issues or have been hospitalized for COPD or diabetes complications recently.My kidney function, measured by creatinine levels, is within the required range.You have a mental illness or social situation that would make it hard for you to follow the study rules.I haven't had chemotherapy, surgery, or certain cancer drugs for the required waiting period before joining.My hepatitis B virus is undetectable with treatment.I have not taken antibiotics for a major infection within 72 hours before my first dose of the study drug.I have a weakened immune system due to medication or a known condition.I have side effects from cancer treatment, but they are mild except for possible nerve pain.Your bilirubin level in the blood is not higher than the normal limit.
- Group 1: Arm I (PIPAC, doxorubicin, cisplatin)
- Group 2: Arm II (PIPAC, oxaliplatin, leucovorin, fluorouracil)
- Group 3: Arm III (PIPAC, mitomycin, FOLFIRI)
- 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
What potential side effects or risks should be expected from Intraperitoneal Chemotherapy?
"The safety of intraperitoneal chemotherapy is graded at 1, signifying that the data supporting both its efficacy and security are neither comprehensive nor conclusive."
How many people have joined this research endeavor?
"Affirmative. The information posted on clinicaltrials.gov confirms that this trial is actively recruiting patients, having been first announced on August 21st 2020 and recently updated on May 4th 2022. A total of 49 participants need to be enrolled from 5 different sites for the study's completion."
Are there any available vacancies for participants in this clinical trial?
"According to the clinicaltrials.gov page, this trial is accepting patient enrollment and has been since August 21st 2020 with a most recent update occuring on May 4th 2022."
Could you please elucidate other research findings involving Intraperitoneal Chemotherapy?
"At present, 1545 clinical trials are being conducted on Intraperitoneal Chemotherapy. The majority of these studies (546) is in its third stage while the remainder of them are spread across 85461 medical centres based mostly in Guangzhou, Guangdong."
In how many locales can this research be accessed?
"This research is being conducted in 5 distinct sites, with Duarte and New york/Greenlawn among them. If you wish to partake in the trial, it is best that your chosen site be close by so as to minimize any travelling demands."
Is this investigation unprecedented in nature?
"Since its initial 1997 clinical trial, sponsored by Alfacell, Intraperitoneal Chemotherapy has undergone an extensive study process to gain Phase 3 drug approval. Currently there exist 1545 active trials for this medication in 3924 cities and 82 countries worldwide."
What pathologies are commonly treated using Intraperitoneal Chemotherapy?
"Intraperitoneal Chemotherapy has been utilized to manage myelocytic leukemia, acute lymphoma, and neuroblastoma (nb) in patients."
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