Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT07282834
Brief Summary:
This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or "IP" chemotherapy).
The study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.
Detailed Description:
Mitomycin C is the chemotherapy that is being administered but it is not being evaluated in the study. Mitomycin C is an FDA-approved antineoplastic antibiotic, meaning it's a type of chemotherapy drug used to treat cancer. It works by interfering with DNA synthesis, which is essential for cell growth and division. By disrupting DNA, mitomycin C can prevent cancer cells from multiplying and spreading.
The study will enroll up to 200 patients who will be randomly assigned (like the flip of a coin) to receive either HIPEC or PIPAC. Participants will be active on the study for 120-180 days.
During the study, patients will undergo standard diagnostic laparoscopies (a minimally invasive surgical procedure) to assess their eligibility for surgery to remove as much cancer as possible. Before treatment begins, small tissue samples (biopsies) will be taken for analysis in the pathology department. A small portion of this tissue will be saved by the researchers to study the effects of treatment on tumors. Patients will then receive three rounds of chemotherapy administered by either HIPEC or PIPAC, each about six weeks apart, and each during a laparoscopic procedure. Tumor tissue biopsies will be collected at the time of each treatment for analysis in the pathology department, and a small portion of each biopsy will again be saved by the researchers for laboratory work to study the effects of the treatment on tumors.
Finally, patients will have another laparoscopy to assess the treatment's effect and check for any side effects. Although patients will be followed for up to 5 years, no study-specific follow-up visits are required. Participants undergoing this type of treatment also complete quality-of-life surveys at the start of the study, and after each IP chemotherapy treatment, that asks about general health, well-being and ability to do daily activities. Patient responses to these surveys are collected for research purposes.
HIPEC and PIPAC chemotherapy, are already standard ways to treat PC. This means there's no extra risk to study participants. However, as with any treatment, there are some potential risks, such as infection inside the abdomen or injury to organs during the procedure to deliver the chemotherapy. These risks are small and would be the same whether the participant were in the study or receiving these treatments as part of their normal care.
Study:
NCT07282834
Study Brief:
Protocol Section:
NCT07282834