RecruitingPhase IIIEN originalColorectal cancerMetastatic / advanced

Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This phase III trial studies how well pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with mitomycin works versus (vs) standard chemotherapy (leucovorin calcium, fluorouracil, and irinotecan hydrochloride \[FOLFIRI regimen\] plus bevacizumab) in treating patients with appendix or colorectal cancer that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to the abdominal cavity (peritoneal metastases). PIPAC is a new therapeutic approach that is minimally invasive, does not require surgery (laparotomy), and can be frequently repeated. Chemotherapy is delivered as a pressurized mist directly inside the abdominal cavity (peritoneum) during a minimally invasive surgery called a laparoscopy. The pressure helps the chemotherapy absorb into the cancer tissue and spread more evenly. Mitomycin is an antibiotic used as a chemotherapy drug. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their deoxyribonucleic acid (DNA). Standard chemotherapy drugs, such as those in the FOLFIRI regimen, are given via infusion into a vein (intravenously), and work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Another standard intravenous drug, bevacizumab, is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving mitomycin via PIPAC in combination with the standard FOLFIRI regimen, with or without bevacizumab, may work better than standard FOLFIRI plus bevacizumab alone in treating patients with unresectable appendix or colorectal cancer with peritoneal metastases.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Pacjent wyraża zgodę na udział w badaniu.
  • •Wiek co najmniej 18 lat.
  • •Pacjent ma potwierdzone przerzuty raka wyrostka lub jelita grubego w jamie brzusznej.
  • •Nie ma innych przerzutów poza płucami (do 5 zmian o wielkości do 1 cm).
  • •Przerzuty w jamie brzusznej są widoczne na badaniach obrazowych lub podczas laparoskopii.
  • •Pacjent zakończył lub przerwał (z powodu nietolerancji) standardowe leczenie pierwszego rzutu trwające co najmniej 4 miesiące bez pogorszenia choroby.
  • •Pacjent nie jest kandydatem do operacji usuwającej guz.
  • •Pacjent w pełni wyzdrowiał po wcześniejszym leczeniu przeciwnowotworowym.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 25, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (5)

CTCA at Western Regional Medical Center

Goodyear, United States

City of Hope Comprehensive Cancer Center

Duarte, United States

City of Hope at Irvine Lennar

Irvine, United States

City of Hope Atlanta Cancer Center

Newnan, United States

City of Hope at Chicago

Zion, United States

Trial contact

Mustafa Raoof

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/26/2026.

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