Comparing flat dose and weight-based chemotherapy for peritoneal carcinomatosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of flat dose versus weight-based dosing of Mitomycin C in patients undergoing cytoreductive surgery and heated intra-peritoneal chemotherapy (HIPEC) for peritoneal carcinomatosis. The study aims to determine which dosing method provides better outcomes in terms of overall survival and treatment efficacy. Participants will be randomly assigned to receive either a flat dose of 40 mg or a weight-based dose of 12.5 mg/m2 of Mitomycin C during their treatment. The trial focuses on patients with specific types of gastrointestinal malignancies that have spread to the peritoneal cavity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
* ECOG performance status \< 3
* Candidate for grossly complete cytoreductive surgery
* Life expectancy greater than 3 months
* Adequate organ and marrow function
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Any extra-abdominal metastases
* Untreated lung metastases
* Liver metastases not amenable to resection or ablation
* Known brain metastases
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Presence of residual significant adverse events attributed to prior cancer treatment
* Currently receiving any other investigational therapeutic agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
* Pregnant or breast-feeding women
* Uncontrolled ongoing illness

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• University of Vermont Medical Center
  Burlington, Vermont, United States Recruiting

Study contacts

• Principal investigator: Prakash Pandalai, MD — University of Kentucky
• Study coordinator: Prakash Pandalai, MD
• Email: Prakash.Pandalai@uky.edu
• Phone: 859-323-8920

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Repeated PIPAC plus standard platinum–taxane chemotherapy for advanced ovarian cancer with peritoneal spread

  This test sees if adding repeated cisplatin-based PIPAC to standard platinum–taxane chemotherapy helps women aged 18–75 with newly diagnosed FIGO IIIB–IIIC epithelial ovarian cancer and visible peritoneal carcinomatosis.

  Recruiting Phase 2 Moscow Regional Oncological Dispensary · Balashikha · NCT07514494

• Enhanced Recovery After Surgery for adults with peritoneal carcinomatosis undergoing cytoreductive surgery with or without HIPEC

  This project will try an Enhanced Recovery After Surgery (ERAS) program to see if it shortens hospital stays after cytoreductive surgery with or without HIPEC for adults with peritoneal carcinomatosis.

  Recruiting Fondazione del Piemonte per l'Oncologia · Candiolo, Turin and 1 other locations · NCT07493876

• PIPAC with Mitomycin C for unresectable peritoneal cancer

  This phase 1 study tests a breathy, pressurized chemotherapy method (PIPAC-MMC) to see if it is safe and tolerable for adults with unresectable peritoneal carcinomatosis from colorectal, appendiceal, or small bowel cancers.

  Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07487168

• Heated versus aerosolized chemotherapy delivered into the abdomen for cancer that has spread to the peritoneum

  This study will test whether heated (HIPEC) or aerosolized (PIPAC) mitomycin-based chemotherapy given into the abdomen works better and is safer for adults whose cancer has spread to the peritoneum.

  Recruiting Phase 2 Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07282834

• Adding paclitaxel into the abdominal cavity for gastric cancer that has spread to the peritoneum

  This trial will try adding paclitaxel delivered directly into the abdomen to standard IV chemotherapy for people with gastric or gastroesophageal junction cancer that has spread to the lining of the abdominal cavity to see if it slows disease growth and helps them live longer.

  Recruiting at 78 sites Phase 2/3 Eastern Cooperative Oncology Group · Irvine, California and 77 other locations · NCT07001748

• Blood clearance of nucleosomes and CTCF after surgery for colorectal cancer with peritoneal spread

  This test will see if blood levels of nucleosomes and CTCF can indicate whether adults with colorectal cancer that has spread to the peritoneum have had all visible tumor removed by cytoreductive surgery.

  Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT06929013

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.