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

Trial Details

NCT ID

NCT07271355

Phase

PHASE3

Sponsor

City of Hope Medical Center

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Bevacizumab
Biopsy Procedure
Biospecimen Collection
Computed Tomography
Fluorouracil
Irinotecan Hydrochloride

Locations (sample)

Goodyear, Arizona, United States|33.43532,-112.35821
Duarte, California, United States|34.13945,-117.97729
Irvine, California, United States|33.66946,-117.82311
Newnan, Georgia, United States|33.38067,-84.79966
Zion, Illinois, United States|42.44613,-87.83285

Key Eligibility Criteria

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval

For full eligibility, visit ClinicalTrials.gov.

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